Ignite Creation Date:
2025-12-24 @ 1:14 PM
Ignite Modification Date:
2026-01-01 @ 1:44 AM
Study NCT ID:
NCT01777295
Status:
COMPLETED
Last Update Posted:
2019-01-04
First Post:
2013-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Development of Read-outs in Healthy, Hepatitis B Virus Naive Adults Vaccinated With the Hepatitis B Surface Antigen (HBsAg) in Combination With a GlaxoSmithKline (GSK) Biologicals' Adjuvant System
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006509', 'term': 'Hepatitis B'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018347', 'term': 'Hepadnaviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006514', 'term': 'Hepatitis B Surface Antigens'}, {'id': 'C075654', 'term': 'Engerix-B'}], 'ancestors': [{'id': 'D006511', 'term': 'Hepatitis B Antigens'}, {'id': 'D018963', 'term': 'Hepatitis Antigens'}, {'id': 'D000956', 'term': 'Antigens, Viral'}, {'id': 'D014764', 'term': 'Viral Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000941', 'term': 'Antigens'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '866-435-7343', 'title': 'GSK Response Center', 'organization': 'GlaxoSmithKline'}, 'certainAgreement': {'otherDetails': 'GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Solicited and unsolicited symptoms: during the 28 Day (Days 0-27) post-vaccination period; SAEs: up to Day 180 for the HBsAg/AS_1+2 Group and up to Day 330 for the Engerix-B_1+2 Group.', 'description': 'The safety analysis did not include subjects who received only the Placebo dose.', 'eventGroups': [{'id': 'EG000', 'title': 'HBsAg/AS_1+2 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30; and during Step 2 of the study, 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.', 'otherNumAtRisk': 38, 'deathsNumAtRisk': 38, 'otherNumAffected': 16, 'seriousNumAtRisk': 38, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Engerix-B_1+2 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180; and during Step 2 of the study, 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.', 'otherNumAtRisk': 40, 'deathsNumAtRisk': 40, 'otherNumAffected': 13, 'seriousNumAtRisk': 40, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Dysmenorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 5, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}], 'seriousEvents': [{'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Concentrations of Cytokines and Chemokines - Step 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HBsAg/AS_1 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}, {'id': 'OG001', 'title': 'Engerix-B_1 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}], 'classes': [{'title': 'E-selectin', 'categories': [{'measurements': [{'value': '6000', 'groupId': 'OG000', 'lowerLimit': '4600', 'upperLimit': '8300'}, {'value': '6250', 'groupId': 'OG001', 'lowerLimit': '4600', 'upperLimit': '7800'}]}]}, {'title': 'GM-CSF', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000', 'lowerLimit': '14', 'upperLimit': '14'}, {'value': '14', 'groupId': 'OG001', 'lowerLimit': '14', 'upperLimit': '14'}]}]}, {'title': 'IFN-γ', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '1.6'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '1.6'}]}]}, {'title': 'IL-10', 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000', 'lowerLimit': '3.3', 'upperLimit': '4.5'}, {'value': '3.3', 'groupId': 'OG001', 'lowerLimit': '3.3', 'upperLimit': '4.1'}]}]}, {'title': 'IL-18', 'categories': [{'measurements': [{'value': '198', 'groupId': 'OG000', 'lowerLimit': '148', 'upperLimit': '290'}, {'value': '177', 'groupId': 'OG001', 'lowerLimit': '152', 'upperLimit': '215'}]}]}, {'title': 'IL-2', 'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000', 'lowerLimit': '5.9', 'upperLimit': '7'}, {'value': '5.9', 'groupId': 'OG001', 'lowerLimit': '5.9', 'upperLimit': '5.9'}]}]}, {'title': 'IL-3', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '1.6'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '1.6'}]}]}, {'title': 'IL-4', 'categories': [{'measurements': [{'value': '9.4', 'groupId': 'OG000', 'lowerLimit': '9.4', 'upperLimit': '9.4'}, {'value': '9.4', 'groupId': 'OG001', 'lowerLimit': '9.4', 'upperLimit': '9.4'}]}]}, {'title': 'IL-5', 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000', 'lowerLimit': '2.7', 'upperLimit': '2.7'}, {'value': '2.7', 'groupId': 'OG001', 'lowerLimit': '2.7', 'upperLimit': '2.7'}]}]}, {'title': 'IL-6', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '1.6'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '1.6'}]}]}, {'title': 'IL-6r', 'categories': [{'measurements': [{'value': '26000', 'groupId': 'OG000', 'lowerLimit': '20000', 'upperLimit': '30000'}, {'value': '22500', 'groupId': 'OG001', 'lowerLimit': '22000', 'upperLimit': '30000'}]}]}, {'title': 'IL-7', 'categories': [{'measurements': [{'value': '8.2', 'groupId': 'OG000', 'lowerLimit': '8.2', 'upperLimit': '8.2'}, {'value': '8.2', 'groupId': 'OG001', 'lowerLimit': '8.2', 'upperLimit': '8.2'}]}]}, {'title': 'IL-8', 'categories': [{'measurements': [{'value': '5.7', 'groupId': 'OG000', 'lowerLimit': '4.2', 'upperLimit': '6.6'}, {'value': '5.1', 'groupId': 'OG001', 'lowerLimit': '3.9', 'upperLimit': '5.9'}]}]}, {'title': 'IP-10', 'categories': [{'measurements': [{'value': '225', 'groupId': 'OG000', 'lowerLimit': '176', 'upperLimit': '402'}, {'value': '247.5', 'groupId': 'OG001', 'lowerLimit': '195', 'upperLimit': '280'}]}]}, {'title': 'MCP-1', 'categories': [{'measurements': [{'value': '107', 'groupId': 'OG000', 'lowerLimit': '89', 'upperLimit': '142'}, {'value': '98.5', 'groupId': 'OG001', 'lowerLimit': '83', 'upperLimit': '117'}]}]}, {'title': 'MCP-2', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000', 'lowerLimit': '13', 'upperLimit': '25'}, {'value': '19.5', 'groupId': 'OG001', 'lowerLimit': '17', 'upperLimit': '26'}]}]}, {'title': 'MCP-4', 'categories': [{'measurements': [{'value': '1230', 'groupId': 'OG000', 'lowerLimit': '1070', 'upperLimit': '1550'}, {'value': '1170', 'groupId': 'OG001', 'lowerLimit': '1100', 'upperLimit': '1600'}]}]}, {'title': 'MIG', 'categories': [{'measurements': [{'value': '513', 'groupId': 'OG000', 'lowerLimit': '354', 'upperLimit': '682'}, {'value': '435', 'groupId': 'OG001', 'lowerLimit': '285', 'upperLimit': '674'}]}]}, {'title': 'MIP-1 alpha', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000', 'lowerLimit': '18', 'upperLimit': '25'}, {'value': '20', 'groupId': 'OG001', 'lowerLimit': '18', 'upperLimit': '24'}]}]}, {'title': 'MIP-1 beta', 'categories': [{'measurements': [{'value': '190', 'groupId': 'OG000', 'lowerLimit': '162', 'upperLimit': '228'}, {'value': '138', 'groupId': 'OG001', 'lowerLimit': '126', 'upperLimit': '205'}]}]}, {'title': 'MIP-3 alpha', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000', 'lowerLimit': '11', 'upperLimit': '32'}, {'value': '18', 'groupId': 'OG001', 'lowerLimit': '11', 'upperLimit': '28'}]}]}, {'title': 'MPIF-1', 'categories': [{'measurements': [{'value': '1600', 'groupId': 'OG000', 'lowerLimit': '1200', 'upperLimit': '1800'}, {'value': '1450', 'groupId': 'OG001', 'lowerLimit': '1200', 'upperLimit': '1600'}]}]}, {'title': 'TNF-alpha', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000', 'lowerLimit': '13', 'upperLimit': '13'}, {'value': '13', 'groupId': 'OG001', 'lowerLimit': '13', 'upperLimit': '13'}]}]}, {'title': 'TNF-beta', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '3'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At Day -30 prior to placebo administration', 'description': 'Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyses were performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).'}, {'type': 'PRIMARY', 'title': 'Cytokines and Chemokines Concentrations - Step 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HBsAg/AS_1 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}, {'id': 'OG001', 'title': 'Engerix-B_1 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}], 'classes': [{'title': 'E-selectin', 'categories': [{'measurements': [{'value': '5900', 'groupId': 'OG000', 'lowerLimit': '4100', 'upperLimit': '8500'}, {'value': '6450', 'groupId': 'OG001', 'lowerLimit': '4500', 'upperLimit': '7600'}]}]}, {'title': 'GM-CSF', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000', 'lowerLimit': '14', 'upperLimit': '14'}, {'value': '14', 'groupId': 'OG001', 'lowerLimit': '14', 'upperLimit': '14'}]}]}, {'title': 'IFN-γ', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '1.6'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '1.6'}]}]}, {'title': 'IL-10', 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000', 'lowerLimit': '3.3', 'upperLimit': '3.7'}, {'value': '3.3', 'groupId': 'OG001', 'lowerLimit': '3.3', 'upperLimit': '3.7'}]}]}, {'title': 'IL-18', 'categories': [{'measurements': [{'value': '172', 'groupId': 'OG000', 'lowerLimit': '141', 'upperLimit': '225'}, {'value': '179.5', 'groupId': 'OG001', 'lowerLimit': '136', 'upperLimit': '215'}]}]}, {'title': 'IL-2', 'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000', 'lowerLimit': '5.9', 'upperLimit': '7'}, {'value': '5.9', 'groupId': 'OG001', 'lowerLimit': '5.9', 'upperLimit': '6.3'}]}]}, {'title': 'IL-3', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '1.6'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '1.6'}]}]}, {'title': 'IL-4', 'categories': [{'measurements': [{'value': '9.4', 'groupId': 'OG000', 'lowerLimit': '9.4', 'upperLimit': '9.4'}, {'value': '9.4', 'groupId': 'OG001', 'lowerLimit': '9.4', 'upperLimit': '9.4'}]}]}, {'title': 'IL-5', 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000', 'lowerLimit': '2.7', 'upperLimit': '2.7'}, {'value': '2.7', 'groupId': 'OG001', 'lowerLimit': '2.7', 'upperLimit': '2.7'}]}]}, {'title': 'IL-6', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '1.6'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '1.6'}]}]}, {'title': 'IL-6r', 'categories': [{'measurements': [{'value': '26000', 'groupId': 'OG000', 'lowerLimit': '21000', 'upperLimit': '30000'}, {'value': '22000', 'groupId': 'OG001', 'lowerLimit': '19000', 'upperLimit': '29000'}]}]}, {'title': 'IL-7', 'categories': [{'measurements': [{'value': '8.2', 'groupId': 'OG000', 'lowerLimit': '8.2', 'upperLimit': '8.2'}, {'value': '8.2', 'groupId': 'OG001', 'lowerLimit': '8.2', 'upperLimit': '8.2'}]}]}, {'title': 'IL-8', 'categories': [{'measurements': [{'value': '4.2', 'groupId': 'OG000', 'lowerLimit': '3.7', 'upperLimit': '4.9'}, {'value': '4.2', 'groupId': 'OG001', 'lowerLimit': '3.2', 'upperLimit': '5.3'}]}]}, {'title': 'IP-10', 'categories': [{'measurements': [{'value': '220', 'groupId': 'OG000', 'lowerLimit': '183', 'upperLimit': '330'}, {'value': '207', 'groupId': 'OG001', 'lowerLimit': '172', 'upperLimit': '240'}]}]}, {'title': 'MCP-1', 'categories': [{'measurements': [{'value': '79', 'groupId': 'OG000', 'lowerLimit': '58', 'upperLimit': '101'}, {'value': '77.5', 'groupId': 'OG001', 'lowerLimit': '63', 'upperLimit': '96'}]}]}, {'title': 'MCP-2', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000', 'lowerLimit': '13', 'upperLimit': '24'}, {'value': '19', 'groupId': 'OG001', 'lowerLimit': '14', 'upperLimit': '25'}]}]}, {'title': 'MCP-4', 'categories': [{'measurements': [{'value': '1300', 'groupId': 'OG000', 'lowerLimit': '933', 'upperLimit': '1480'}, {'value': '1190', 'groupId': 'OG001', 'lowerLimit': '896', 'upperLimit': '1300'}]}]}, {'title': 'MIG', 'categories': [{'measurements': [{'value': '392', 'groupId': 'OG000', 'lowerLimit': '344', 'upperLimit': '575'}, {'value': '336', 'groupId': 'OG001', 'lowerLimit': '269', 'upperLimit': '487'}]}]}, {'title': 'MIP-1 alpha', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000', 'lowerLimit': '18', 'upperLimit': '21'}, {'value': '18', 'groupId': 'OG001', 'lowerLimit': '18', 'upperLimit': '19'}]}]}, {'title': 'MIP-1 beta', 'categories': [{'measurements': [{'value': '141', 'groupId': 'OG000', 'lowerLimit': '108', 'upperLimit': '191'}, {'value': '124.5', 'groupId': 'OG001', 'lowerLimit': '107', 'upperLimit': '151'}]}]}, {'title': 'MIP-3 alpha', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000', 'lowerLimit': '13', 'upperLimit': '27'}, {'value': '16', 'groupId': 'OG001', 'lowerLimit': '13', 'upperLimit': '22'}]}]}, {'title': 'MPIF-1', 'categories': [{'measurements': [{'value': '1500', 'groupId': 'OG000', 'lowerLimit': '1200', 'upperLimit': '1600'}, {'value': '1400', 'groupId': 'OG001', 'lowerLimit': '1000', 'upperLimit': '1600'}]}]}, {'title': 'TNF-alpha', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000', 'lowerLimit': '13', 'upperLimit': '13'}, {'value': '13', 'groupId': 'OG001', 'lowerLimit': '13', 'upperLimit': '13'}]}]}, {'title': 'TNF-beta', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '3'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Post-placebo at Day -30 plus 1.5 Hours', 'description': 'Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyses were performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).'}, {'type': 'PRIMARY', 'title': 'Concentrations of Cytokines and Chemokines in Step 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HBsAg/AS_1 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}, {'id': 'OG001', 'title': 'Engerix-B_1 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}], 'classes': [{'title': 'E-selectin', 'categories': [{'measurements': [{'value': '5600', 'groupId': 'OG000', 'lowerLimit': '3800', 'upperLimit': '7800'}, {'value': '6300', 'groupId': 'OG001', 'lowerLimit': '4100', 'upperLimit': '7600'}]}]}, {'title': 'GM-CSF', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000', 'lowerLimit': '14', 'upperLimit': '14'}, {'value': '14', 'groupId': 'OG001', 'lowerLimit': '14', 'upperLimit': '14'}]}]}, {'title': 'IFN-γ', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '1.6'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '1.6'}]}]}, {'title': 'IL-10', 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000', 'lowerLimit': '3.3', 'upperLimit': '4.2'}, {'value': '3.3', 'groupId': 'OG001', 'lowerLimit': '3.3', 'upperLimit': '3.4'}]}]}, {'title': 'IL-18', 'categories': [{'measurements': [{'value': '168', 'groupId': 'OG000', 'lowerLimit': '154', 'upperLimit': '283'}, {'value': '173', 'groupId': 'OG001', 'lowerLimit': '142', 'upperLimit': '202'}]}]}, {'title': 'IL-2', 'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000', 'lowerLimit': '5.9', 'upperLimit': '7.4'}, {'value': '5.9', 'groupId': 'OG001', 'lowerLimit': '5.9', 'upperLimit': '5.9'}]}]}, {'title': 'IL-3', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '1.6'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '1.6'}]}]}, {'title': 'IL-4', 'categories': [{'measurements': [{'value': '9.4', 'groupId': 'OG000', 'lowerLimit': '9.4', 'upperLimit': '9.4'}, {'value': '9.4', 'groupId': 'OG001', 'lowerLimit': '9.4', 'upperLimit': '9.4'}]}]}, {'title': 'IL-5', 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000', 'lowerLimit': '2.7', 'upperLimit': '2.7'}, {'value': '2.7', 'groupId': 'OG001', 'lowerLimit': '2.7', 'upperLimit': '2.7'}]}]}, {'title': 'IL-6', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '1.6'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '1.6'}]}]}, {'title': 'IL-6r', 'categories': [{'measurements': [{'value': '28000', 'groupId': 'OG000', 'lowerLimit': '22000', 'upperLimit': '34000'}, {'value': '26000', 'groupId': 'OG001', 'lowerLimit': '21000', 'upperLimit': '33000'}]}]}, {'title': 'IL-7', 'categories': [{'measurements': [{'value': '8.2', 'groupId': 'OG000', 'lowerLimit': '8.2', 'upperLimit': '8.2'}, {'value': '8.2', 'groupId': 'OG001', 'lowerLimit': '8.2', 'upperLimit': '8.2'}]}]}, {'title': 'IL-8', 'categories': [{'measurements': [{'value': '4.2', 'groupId': 'OG000', 'lowerLimit': '3.5', 'upperLimit': '6.4'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '3.2', 'upperLimit': '5.3'}]}]}, {'title': 'IP-10', 'categories': [{'measurements': [{'value': '223', 'groupId': 'OG000', 'lowerLimit': '169', 'upperLimit': '396'}, {'value': '217.5', 'groupId': 'OG001', 'lowerLimit': '175', 'upperLimit': '251'}]}]}, {'title': 'MCP-1', 'categories': [{'measurements': [{'value': '79', 'groupId': 'OG000', 'lowerLimit': '65', 'upperLimit': '92'}, {'value': '64', 'groupId': 'OG001', 'lowerLimit': '48', 'upperLimit': '104'}]}]}, {'title': 'MCP-2', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000', 'lowerLimit': '14', 'upperLimit': '27'}, {'value': '20', 'groupId': 'OG001', 'lowerLimit': '18', 'upperLimit': '23'}]}]}, {'title': 'MCP-4', 'categories': [{'measurements': [{'value': '1170', 'groupId': 'OG000', 'lowerLimit': '951', 'upperLimit': '1440'}, {'value': '1175', 'groupId': 'OG001', 'lowerLimit': '1060', 'upperLimit': '1310'}]}]}, {'title': 'MIG', 'categories': [{'measurements': [{'value': '439', 'groupId': 'OG000', 'lowerLimit': '347', 'upperLimit': '558'}, {'value': '343', 'groupId': 'OG001', 'lowerLimit': '285', 'upperLimit': '504'}]}]}, {'title': 'MIP-1 alpha', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000', 'lowerLimit': '18', 'upperLimit': '21'}, {'value': '18', 'groupId': 'OG001', 'lowerLimit': '18', 'upperLimit': '21'}]}]}, {'title': 'MIP-1 beta', 'categories': [{'measurements': [{'value': '163', 'groupId': 'OG000', 'lowerLimit': '120', 'upperLimit': '199'}, {'value': '127', 'groupId': 'OG001', 'lowerLimit': '112', 'upperLimit': '147'}]}]}, {'title': 'MIP-3 alpha', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000', 'lowerLimit': '12', 'upperLimit': '27'}, {'value': '18', 'groupId': 'OG001', 'lowerLimit': '14', 'upperLimit': '22'}]}]}, {'title': 'MPIF-1', 'categories': [{'measurements': [{'value': '1600', 'groupId': 'OG000', 'lowerLimit': '1200', 'upperLimit': '1900'}, {'value': '1300', 'groupId': 'OG001', 'lowerLimit': '1000', 'upperLimit': '1500'}]}]}, {'title': 'TNF-alpha', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000', 'lowerLimit': '13', 'upperLimit': '13'}, {'value': '13', 'groupId': 'OG001', 'lowerLimit': '13', 'upperLimit': '13'}]}]}, {'title': 'TNF-beta', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '3'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Post-placebo at Day -30 plus 3 Hours', 'description': 'Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).'}, {'type': 'PRIMARY', 'title': 'Concentrations of Cytokines and Chemokines During Step 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HBsAg/AS_1 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}, {'id': 'OG001', 'title': 'Engerix-B_1 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}], 'classes': [{'title': 'E-selectin', 'categories': [{'measurements': [{'value': '5200', 'groupId': 'OG000', 'lowerLimit': '3900', 'upperLimit': '8300'}, {'value': '6050', 'groupId': 'OG001', 'lowerLimit': '4200', 'upperLimit': '8100'}]}]}, {'title': 'GM-CSF', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000', 'lowerLimit': '14', 'upperLimit': '14'}, {'value': '14', 'groupId': 'OG001', 'lowerLimit': '14', 'upperLimit': '14'}]}]}, {'title': 'IFN-γ', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '1.6'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '1.6'}]}]}, {'title': 'IL-10', 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000', 'lowerLimit': '3.3', 'upperLimit': '4.6'}, {'value': '3.3', 'groupId': 'OG001', 'lowerLimit': '3.3', 'upperLimit': '3.6'}]}]}, {'title': 'IL-18', 'categories': [{'measurements': [{'value': '176', 'groupId': 'OG000', 'lowerLimit': '160', 'upperLimit': '273'}, {'value': '177.5', 'groupId': 'OG001', 'lowerLimit': '132', 'upperLimit': '233'}]}]}, {'title': 'IL-2', 'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000', 'lowerLimit': '5.9', 'upperLimit': '5.9'}, {'value': '5.9', 'groupId': 'OG001', 'lowerLimit': '5.9', 'upperLimit': '6'}]}]}, {'title': 'IL-3', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '1.6'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '1.6'}]}]}, {'title': 'IL-4', 'categories': [{'measurements': [{'value': '9.4', 'groupId': 'OG000', 'lowerLimit': '9.4', 'upperLimit': '9.4'}, {'value': '9.4', 'groupId': 'OG001', 'lowerLimit': '9.4', 'upperLimit': '9.4'}]}]}, {'title': 'IL-5', 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000', 'lowerLimit': '2.7', 'upperLimit': '2.7'}, {'value': '2.7', 'groupId': 'OG001', 'lowerLimit': '2.7', 'upperLimit': '2.7'}]}]}, {'title': 'IL-6', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '2'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '1.6'}]}]}, {'title': 'IL-6r', 'categories': [{'measurements': [{'value': '27000', 'groupId': 'OG000', 'lowerLimit': '21000', 'upperLimit': '32000'}, {'value': '24500', 'groupId': 'OG001', 'lowerLimit': '20000', 'upperLimit': '33000'}]}]}, {'title': 'IL-7', 'categories': [{'measurements': [{'value': '8.2', 'groupId': 'OG000', 'lowerLimit': '8.2', 'upperLimit': '8.2'}, {'value': '8.2', 'groupId': 'OG001', 'lowerLimit': '8.2', 'upperLimit': '8.2'}]}]}, {'title': 'IL-8', 'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000', 'lowerLimit': '3.7', 'upperLimit': '6'}, {'value': '4.5', 'groupId': 'OG001', 'lowerLimit': '3.9', 'upperLimit': '5.8'}]}]}, {'title': 'IP-10', 'categories': [{'measurements': [{'value': '217', 'groupId': 'OG000', 'lowerLimit': '177', 'upperLimit': '400'}, {'value': '218', 'groupId': 'OG001', 'lowerLimit': '174', 'upperLimit': '252'}]}]}, {'title': 'MCP-1', 'categories': [{'measurements': [{'value': '104', 'groupId': 'OG000', 'lowerLimit': '76', 'upperLimit': '119'}, {'value': '101', 'groupId': 'OG001', 'lowerLimit': '76', 'upperLimit': '129'}]}]}, {'title': 'MCP-2', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000', 'lowerLimit': '14', 'upperLimit': '24'}, {'value': '20.5', 'groupId': 'OG001', 'lowerLimit': '16', 'upperLimit': '23'}]}]}, {'title': 'MCP-4', 'categories': [{'measurements': [{'value': '1310', 'groupId': 'OG000', 'lowerLimit': '1030', 'upperLimit': '1570'}, {'value': '1245', 'groupId': 'OG001', 'lowerLimit': '1110', 'upperLimit': '1490'}]}]}, {'title': 'MIG', 'categories': [{'measurements': [{'value': '500', 'groupId': 'OG000', 'lowerLimit': '320', 'upperLimit': '614'}, {'value': '378', 'groupId': 'OG001', 'lowerLimit': '313', 'upperLimit': '566'}]}]}, {'title': 'MIP-1 alpha', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000', 'lowerLimit': '18', 'upperLimit': '21'}, {'value': '18', 'groupId': 'OG001', 'lowerLimit': '18', 'upperLimit': '19'}]}]}, {'title': 'MIP-1 beta', 'categories': [{'measurements': [{'value': '166', 'groupId': 'OG000', 'lowerLimit': '140', 'upperLimit': '215'}, {'value': '146', 'groupId': 'OG001', 'lowerLimit': '129', 'upperLimit': '180'}]}]}, {'title': 'MIP-3 alpha', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000', 'lowerLimit': '15', 'upperLimit': '26'}, {'value': '20', 'groupId': 'OG001', 'lowerLimit': '15', 'upperLimit': '24'}]}]}, {'title': 'MPIF-1', 'categories': [{'measurements': [{'value': '1500', 'groupId': 'OG000', 'lowerLimit': '1200', 'upperLimit': '1800'}, {'value': '1400', 'groupId': 'OG001', 'lowerLimit': '1100', 'upperLimit': '1700'}]}]}, {'title': 'TNF-alpha', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000', 'lowerLimit': '13', 'upperLimit': '13'}, {'value': '13', 'groupId': 'OG001', 'lowerLimit': '13', 'upperLimit': '13'}]}]}, {'title': 'TNF-beta', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '3'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Post-placebo at Day -30 plus 6 Hours', 'description': 'Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).'}, {'type': 'PRIMARY', 'title': 'Concentrations of Cytokines/Chemokines - Step 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HBsAg/AS_1 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}, {'id': 'OG001', 'title': 'Engerix-B_1 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}], 'classes': [{'title': 'E-selectin', 'categories': [{'measurements': [{'value': '5300', 'groupId': 'OG000', 'lowerLimit': '3600', 'upperLimit': '7100'}, {'value': '6100', 'groupId': 'OG001', 'lowerLimit': '4600', 'upperLimit': '7500'}]}]}, {'title': 'GM-CSF', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000', 'lowerLimit': '14', 'upperLimit': '14'}, {'value': '14', 'groupId': 'OG001', 'lowerLimit': '14', 'upperLimit': '14'}]}]}, {'title': 'IFN-γ', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '1.6'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '1.6'}]}]}, {'title': 'IL-10', 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000', 'lowerLimit': '3.3', 'upperLimit': '4.8'}, {'value': '3.3', 'groupId': 'OG001', 'lowerLimit': '3.3', 'upperLimit': '3.3'}]}]}, {'title': 'IL-18', 'categories': [{'measurements': [{'value': '173', 'groupId': 'OG000', 'lowerLimit': '139', 'upperLimit': '226'}, {'value': '167.5', 'groupId': 'OG001', 'lowerLimit': '117', 'upperLimit': '202'}]}]}, {'title': 'IL-2', 'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000', 'lowerLimit': '5.9', 'upperLimit': '14'}, {'value': '5.9', 'groupId': 'OG001', 'lowerLimit': '5.9', 'upperLimit': '7.2'}]}]}, {'title': 'IL-3', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '1.6'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '1.6'}]}]}, {'title': 'IL-4', 'categories': [{'measurements': [{'value': '9.4', 'groupId': 'OG000', 'lowerLimit': '9.4', 'upperLimit': '9.4'}, {'value': '9.4', 'groupId': 'OG001', 'lowerLimit': '9.4', 'upperLimit': '9.4'}]}]}, {'title': 'IL-5', 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000', 'lowerLimit': '2.7', 'upperLimit': '2.7'}, {'value': '2.7', 'groupId': 'OG001', 'lowerLimit': '2.7', 'upperLimit': '2.7'}]}]}, {'title': 'IL-6', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '2.7'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '1.6'}]}]}, {'title': 'IL-6r', 'categories': [{'measurements': [{'value': '24000', 'groupId': 'OG000', 'lowerLimit': '19000', 'upperLimit': '31000'}, {'value': '26000', 'groupId': 'OG001', 'lowerLimit': '19000', 'upperLimit': '29000'}]}]}, {'title': 'IL-7', 'categories': [{'measurements': [{'value': '8.2', 'groupId': 'OG000', 'lowerLimit': '8.2', 'upperLimit': '8.2'}, {'value': '8.2', 'groupId': 'OG001', 'lowerLimit': '8.2', 'upperLimit': '8.2'}]}]}, {'title': 'IL-8', 'categories': [{'measurements': [{'value': '4.9', 'groupId': 'OG000', 'lowerLimit': '3.7', 'upperLimit': '6.9'}, {'value': '4.5', 'groupId': 'OG001', 'lowerLimit': '3.6', 'upperLimit': '5.3'}]}]}, {'title': 'IP-10', 'categories': [{'measurements': [{'value': '210', 'groupId': 'OG000', 'lowerLimit': '162', 'upperLimit': '327'}, {'value': '205.5', 'groupId': 'OG001', 'lowerLimit': '159', 'upperLimit': '227'}]}]}, {'title': 'MCP-1', 'categories': [{'measurements': [{'value': '86', 'groupId': 'OG000', 'lowerLimit': '65', 'upperLimit': '104'}, {'value': '81', 'groupId': 'OG001', 'lowerLimit': '61', 'upperLimit': '109'}]}]}, {'title': 'MCP-2', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000', 'lowerLimit': '15', 'upperLimit': '24'}, {'value': '17', 'groupId': 'OG001', 'lowerLimit': '15', 'upperLimit': '21'}]}]}, {'title': 'MCP-4', 'categories': [{'measurements': [{'value': '1310', 'groupId': 'OG000', 'lowerLimit': '1050', 'upperLimit': '1610'}, {'value': '1145', 'groupId': 'OG001', 'lowerLimit': '944', 'upperLimit': '1400'}]}]}, {'title': 'MIG', 'categories': [{'measurements': [{'value': '452', 'groupId': 'OG000', 'lowerLimit': '313', 'upperLimit': '610'}, {'value': '327', 'groupId': 'OG001', 'lowerLimit': '244', 'upperLimit': '528'}]}]}, {'title': 'MIP-1 alpha', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000', 'lowerLimit': '18', 'upperLimit': '22'}, {'value': '18', 'groupId': 'OG001', 'lowerLimit': '18', 'upperLimit': '18'}]}]}, {'title': 'MIP-1 beta', 'categories': [{'measurements': [{'value': '131', 'groupId': 'OG000', 'lowerLimit': '111', 'upperLimit': '185'}, {'value': '119.5', 'groupId': 'OG001', 'lowerLimit': '102', 'upperLimit': '134'}]}]}, {'title': 'MIP-3 alpha', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000', 'lowerLimit': '11', 'upperLimit': '25'}, {'value': '15', 'groupId': 'OG001', 'lowerLimit': '11', 'upperLimit': '17'}]}]}, {'title': 'MPIF-1', 'categories': [{'measurements': [{'value': '1400', 'groupId': 'OG000', 'lowerLimit': '1100', 'upperLimit': '1800'}, {'value': '1200', 'groupId': 'OG001', 'lowerLimit': '1000', 'upperLimit': '1400'}]}]}, {'title': 'TNF-alpha', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000', 'lowerLimit': '13', 'upperLimit': '13'}, {'value': '13', 'groupId': 'OG001', 'lowerLimit': '13', 'upperLimit': '13'}]}]}, {'title': 'TNF-beta', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '3'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Post-placebo at Day -30 plus 9 Hours', 'description': 'Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).'}, {'type': 'PRIMARY', 'title': 'Concentrations of Cytokines/Chemokines in Step 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HBsAg/AS_1 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}, {'id': 'OG001', 'title': 'Engerix-B_1 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}], 'classes': [{'title': 'E-selectin', 'categories': [{'measurements': [{'value': '5200', 'groupId': 'OG000', 'lowerLimit': '3500', 'upperLimit': '7900'}, {'value': '5600', 'groupId': 'OG001', 'lowerLimit': '4000', 'upperLimit': '7800'}]}]}, {'title': 'GM-CSF', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000', 'lowerLimit': '14', 'upperLimit': '14'}, {'value': '14', 'groupId': 'OG001', 'lowerLimit': '14', 'upperLimit': '14'}]}]}, {'title': 'IFN-γ', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '1.6'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '1.6'}]}]}, {'title': 'IL-10', 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000', 'lowerLimit': '3.3', 'upperLimit': '3.3'}, {'value': '3.3', 'groupId': 'OG001', 'lowerLimit': '3.3', 'upperLimit': '3.3'}]}]}, {'title': 'IL-18', 'categories': [{'measurements': [{'value': '171', 'groupId': 'OG000', 'lowerLimit': '150', 'upperLimit': '244'}, {'value': '180', 'groupId': 'OG001', 'lowerLimit': '131', 'upperLimit': '222'}]}]}, {'title': 'IL-2', 'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000', 'lowerLimit': '5.9', 'upperLimit': '6.3'}, {'value': '5.9', 'groupId': 'OG001', 'lowerLimit': '5.9', 'upperLimit': '6.3'}]}]}, {'title': 'IL-3', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '1.6'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '1.6'}]}]}, {'title': 'IL-4', 'categories': [{'measurements': [{'value': '9.4', 'groupId': 'OG000', 'lowerLimit': '9.4', 'upperLimit': '9.4'}, {'value': '9.4', 'groupId': 'OG001', 'lowerLimit': '9.4', 'upperLimit': '9.4'}]}]}, {'title': 'IL-5', 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000', 'lowerLimit': '2.7', 'upperLimit': '2.7'}, {'value': '2.7', 'groupId': 'OG001', 'lowerLimit': '2.7', 'upperLimit': '2.7'}]}]}, {'title': 'IL-6', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '1.6'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '1.6'}]}]}, {'title': 'IL-6r', 'categories': [{'measurements': [{'value': '26000', 'groupId': 'OG000', 'lowerLimit': '21000', 'upperLimit': '32000'}, {'value': '24000', 'groupId': 'OG001', 'lowerLimit': '21000', 'upperLimit': '34000'}]}]}, {'title': 'IL-7', 'categories': [{'measurements': [{'value': '8.2', 'groupId': 'OG000', 'lowerLimit': '8.2', 'upperLimit': '8.2'}, {'value': '8.2', 'groupId': 'OG001', 'lowerLimit': '8.2', 'upperLimit': '8.2'}]}]}, {'title': 'IL-8', 'categories': [{'measurements': [{'value': '4.6', 'groupId': 'OG000', 'lowerLimit': '3.9', 'upperLimit': '5.9'}, {'value': '4.5', 'groupId': 'OG001', 'lowerLimit': '3.9', 'upperLimit': '5.8'}]}]}, {'title': 'IP-10', 'categories': [{'measurements': [{'value': '217', 'groupId': 'OG000', 'lowerLimit': '160', 'upperLimit': '335'}, {'value': '214', 'groupId': 'OG001', 'lowerLimit': '182', 'upperLimit': '246'}]}]}, {'title': 'MCP-1', 'categories': [{'measurements': [{'value': '117', 'groupId': 'OG000', 'lowerLimit': '79', 'upperLimit': '133'}, {'value': '120', 'groupId': 'OG001', 'lowerLimit': '96', 'upperLimit': '137'}]}]}, {'title': 'MCP-2', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000', 'lowerLimit': '14', 'upperLimit': '26'}, {'value': '19', 'groupId': 'OG001', 'lowerLimit': '17', 'upperLimit': '25'}]}]}, {'title': 'MCP-4', 'categories': [{'measurements': [{'value': '1260', 'groupId': 'OG000', 'lowerLimit': '1000', 'upperLimit': '1480'}, {'value': '1160', 'groupId': 'OG001', 'lowerLimit': '997', 'upperLimit': '1480'}]}]}, {'title': 'MIG', 'categories': [{'measurements': [{'value': '460', 'groupId': 'OG000', 'lowerLimit': '344', 'upperLimit': '623'}, {'value': '412', 'groupId': 'OG001', 'lowerLimit': '341', 'upperLimit': '564'}]}]}, {'title': 'MIP-1 alpha', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000', 'lowerLimit': '18', 'upperLimit': '21'}, {'value': '18', 'groupId': 'OG001', 'lowerLimit': '18', 'upperLimit': '21'}]}]}, {'title': 'MIP-1 beta', 'categories': [{'measurements': [{'value': '159', 'groupId': 'OG000', 'lowerLimit': '120', 'upperLimit': '179'}, {'value': '137', 'groupId': 'OG001', 'lowerLimit': '118', 'upperLimit': '167'}]}]}, {'title': 'MIP-3 alpha', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000', 'lowerLimit': '14', 'upperLimit': '26'}, {'value': '22', 'groupId': 'OG001', 'lowerLimit': '17', 'upperLimit': '28'}]}]}, {'title': 'MPIF-1', 'categories': [{'measurements': [{'value': '1400', 'groupId': 'OG000', 'lowerLimit': '1200', 'upperLimit': '1700'}, {'value': '1300', 'groupId': 'OG001', 'lowerLimit': '1000', 'upperLimit': '1500'}]}]}, {'title': 'TNF-alpha', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000', 'lowerLimit': '13', 'upperLimit': '13'}, {'value': '13', 'groupId': 'OG001', 'lowerLimit': '13', 'upperLimit': '13'}]}]}, {'title': 'TNF-beta', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '3'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Post-placebo at Day -30 plus 12 Hours', 'description': 'Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).'}, {'type': 'PRIMARY', 'title': 'Concentrations of Cytokines/Chemokines During Step 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HBsAg/AS_1 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}, {'id': 'OG001', 'title': 'Engerix-B_1 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}], 'classes': [{'title': 'E-selectin', 'categories': [{'measurements': [{'value': '4950', 'groupId': 'OG000', 'lowerLimit': '2900', 'upperLimit': '6500'}, {'value': '4200', 'groupId': 'OG001', 'lowerLimit': '2700', 'upperLimit': '6300'}]}]}, {'title': 'GM-CSF', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000', 'lowerLimit': '14', 'upperLimit': '14'}, {'value': '14', 'groupId': 'OG001', 'lowerLimit': '14', 'upperLimit': '14'}]}]}, {'title': 'IFN-γ', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '1.6'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '1.6'}]}]}, {'title': 'IL-10', 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000', 'lowerLimit': '3.3', 'upperLimit': '3.6'}, {'value': '3.3', 'groupId': 'OG001', 'lowerLimit': '3.3', 'upperLimit': '3.3'}]}]}, {'title': 'IL-18', 'categories': [{'measurements': [{'value': '174', 'groupId': 'OG000', 'lowerLimit': '118', 'upperLimit': '267'}, {'value': '142', 'groupId': 'OG001', 'lowerLimit': '81', 'upperLimit': '182'}]}]}, {'title': 'IL-2', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000', 'lowerLimit': '5.9', 'upperLimit': '6.3'}, {'value': '5.9', 'groupId': 'OG001', 'lowerLimit': '5.9', 'upperLimit': '6'}]}]}, {'title': 'IL-3', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '1.6'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '1.6'}]}]}, {'title': 'IL-4', 'categories': [{'measurements': [{'value': '9.4', 'groupId': 'OG000', 'lowerLimit': '9.4', 'upperLimit': '9.4'}, {'value': '9.4', 'groupId': 'OG001', 'lowerLimit': '9.4', 'upperLimit': '9.4'}]}]}, {'title': 'IL-5', 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000', 'lowerLimit': '2.7', 'upperLimit': '2.7'}, {'value': '2.7', 'groupId': 'OG001', 'lowerLimit': '2.7', 'upperLimit': '2.7'}]}]}, {'title': 'IL-6', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '1.6'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '2.4'}]}]}, {'title': 'IL-6r', 'categories': [{'measurements': [{'value': '21500', 'groupId': 'OG000', 'lowerLimit': '18000', 'upperLimit': '29000'}, {'value': '21000', 'groupId': 'OG001', 'lowerLimit': '18000', 'upperLimit': '28000'}]}]}, {'title': 'IL-7', 'categories': [{'measurements': [{'value': '8.2', 'groupId': 'OG000', 'lowerLimit': '8.2', 'upperLimit': '8.2'}, {'value': '8.2', 'groupId': 'OG001', 'lowerLimit': '8.2', 'upperLimit': '8.2'}]}]}, {'title': 'IL-8', 'categories': [{'measurements': [{'value': '5.5', 'groupId': 'OG000', 'lowerLimit': '4.6', 'upperLimit': '8.2'}, {'value': '6.1', 'groupId': 'OG001', 'lowerLimit': '4.9', 'upperLimit': '7.8'}]}]}, {'title': 'IP-10', 'categories': [{'measurements': [{'value': '243.5', 'groupId': 'OG000', 'lowerLimit': '174', 'upperLimit': '386'}, {'value': '238', 'groupId': 'OG001', 'lowerLimit': '170', 'upperLimit': '483'}]}]}, {'title': 'MCP-1', 'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000', 'lowerLimit': '76', 'upperLimit': '119'}, {'value': '109', 'groupId': 'OG001', 'lowerLimit': '79', 'upperLimit': '132'}]}]}, {'title': 'MCP-2', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000', 'lowerLimit': '12', 'upperLimit': '26'}, {'value': '17', 'groupId': 'OG001', 'lowerLimit': '16', 'upperLimit': '27'}]}]}, {'title': 'MCP-4', 'categories': [{'measurements': [{'value': '1445', 'groupId': 'OG000', 'lowerLimit': '1130', 'upperLimit': '1640'}, {'value': '1390', 'groupId': 'OG001', 'lowerLimit': '1140', 'upperLimit': '1710'}]}]}, {'title': 'MIG', 'categories': [{'measurements': [{'value': '420', 'groupId': 'OG000', 'lowerLimit': '373', 'upperLimit': '636'}, {'value': '458', 'groupId': 'OG001', 'lowerLimit': '340', 'upperLimit': '811'}]}]}, {'title': 'MIP-1 alpha', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000', 'lowerLimit': '18', 'upperLimit': '26'}, {'value': '18', 'groupId': 'OG001', 'lowerLimit': '18', 'upperLimit': '23'}]}]}, {'title': 'MIP-1 beta', 'categories': [{'measurements': [{'value': '143.5', 'groupId': 'OG000', 'lowerLimit': '136', 'upperLimit': '182'}, {'value': '165', 'groupId': 'OG001', 'lowerLimit': '128', 'upperLimit': '216'}]}]}, {'title': 'MIP-3 alpha', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000', 'lowerLimit': '21', 'upperLimit': '34'}, {'value': '20', 'groupId': 'OG001', 'lowerLimit': '17', 'upperLimit': '38'}]}]}, {'title': 'MPIF-1', 'categories': [{'measurements': [{'value': '1400', 'groupId': 'OG000', 'lowerLimit': '1300', 'upperLimit': '1700'}, {'value': '1100', 'groupId': 'OG001', 'lowerLimit': '920', 'upperLimit': '1500'}]}]}, {'title': 'TNF-alpha', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000', 'lowerLimit': '13', 'upperLimit': '13'}, {'value': '13', 'groupId': 'OG001', 'lowerLimit': '13', 'upperLimit': '13'}]}]}, {'title': 'TNF-beta', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '3'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Post-placebo at Day -30 plus 18 Hours', 'description': 'Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).'}, {'type': 'PRIMARY', 'title': 'Cytokines and Chemokines Concentrations in Step 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HBsAg/AS_1 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}, {'id': 'OG001', 'title': 'Engerix-B_1 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}], 'classes': [{'title': 'E-selectin', 'categories': [{'measurements': [{'value': '5900', 'groupId': 'OG000', 'lowerLimit': '4300', 'upperLimit': '8500'}, {'value': '6350', 'groupId': 'OG001', 'lowerLimit': '4500', 'upperLimit': '8600'}]}]}, {'title': 'GM-CSF', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000', 'lowerLimit': '14', 'upperLimit': '14'}, {'value': '14', 'groupId': 'OG001', 'lowerLimit': '14', 'upperLimit': '14'}]}]}, {'title': 'IFN-γ', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '1.6'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '1.6'}]}]}, {'title': 'IL-10', 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000', 'lowerLimit': '3.3', 'upperLimit': '4.5'}, {'value': '3.3', 'groupId': 'OG001', 'lowerLimit': '3.3', 'upperLimit': '3.3'}]}]}, {'title': 'IL-18', 'categories': [{'measurements': [{'value': '186', 'groupId': 'OG000', 'lowerLimit': '149', 'upperLimit': '261'}, {'value': '177.5', 'groupId': 'OG001', 'lowerLimit': '136', 'upperLimit': '242'}]}]}, {'title': 'IL-2', 'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000', 'lowerLimit': '5.9', 'upperLimit': '5.9'}, {'value': '5.9', 'groupId': 'OG001', 'lowerLimit': '5.9', 'upperLimit': '5.9'}]}]}, {'title': 'IL-3', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '1.6'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '1.6'}]}]}, {'title': 'IL-4', 'categories': [{'measurements': [{'value': '9.4', 'groupId': 'OG000', 'lowerLimit': '9.4', 'upperLimit': '9.4'}, {'value': '9.4', 'groupId': 'OG001', 'lowerLimit': '9.4', 'upperLimit': '9.4'}]}]}, {'title': 'IL-5', 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000', 'lowerLimit': '2.7', 'upperLimit': '2.7'}, {'value': '2.7', 'groupId': 'OG001', 'lowerLimit': '2.7', 'upperLimit': '2.7'}]}]}, {'title': 'IL-6', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '1.7'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '1.7'}]}]}, {'title': 'IL-6r', 'categories': [{'measurements': [{'value': '27000', 'groupId': 'OG000', 'lowerLimit': '19000', 'upperLimit': '35000'}, {'value': '26500', 'groupId': 'OG001', 'lowerLimit': '19000', 'upperLimit': '31000'}]}]}, {'title': 'IL-7', 'categories': [{'measurements': [{'value': '8.2', 'groupId': 'OG000', 'lowerLimit': '8.2', 'upperLimit': '8.2'}, {'value': '8.2', 'groupId': 'OG001', 'lowerLimit': '8.2', 'upperLimit': '8.2'}]}]}, {'title': 'IL-8', 'categories': [{'measurements': [{'value': '5.4', 'groupId': 'OG000', 'lowerLimit': '3.9', 'upperLimit': '6.9'}, {'value': '5.2', 'groupId': 'OG001', 'lowerLimit': '4.3', 'upperLimit': '6.8'}]}]}, {'title': 'IP-10', 'categories': [{'measurements': [{'value': '241', 'groupId': 'OG000', 'lowerLimit': '190', 'upperLimit': '345'}, {'value': '244.5', 'groupId': 'OG001', 'lowerLimit': '200', 'upperLimit': '307'}]}]}, {'title': 'MCP-1', 'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000', 'lowerLimit': '73', 'upperLimit': '116'}, {'value': '81.5', 'groupId': 'OG001', 'lowerLimit': '66', 'upperLimit': '104'}]}]}, {'title': 'MCP-2', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000', 'lowerLimit': '15', 'upperLimit': '24'}, {'value': '19', 'groupId': 'OG001', 'lowerLimit': '16', 'upperLimit': '25'}]}]}, {'title': 'MCP-4', 'categories': [{'measurements': [{'value': '1230', 'groupId': 'OG000', 'lowerLimit': '1070', 'upperLimit': '1350'}, {'value': '1170', 'groupId': 'OG001', 'lowerLimit': '1020', 'upperLimit': '1450'}]}]}, {'title': 'MIG', 'categories': [{'measurements': [{'value': '528', 'groupId': 'OG000', 'lowerLimit': '327', 'upperLimit': '695'}, {'value': '418.5', 'groupId': 'OG001', 'lowerLimit': '352', 'upperLimit': '721'}]}]}, {'title': 'MIP-1 alpha', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000', 'lowerLimit': '18', 'upperLimit': '24'}, {'value': '18', 'groupId': 'OG001', 'lowerLimit': '18', 'upperLimit': '21'}]}]}, {'title': 'MIP-1 beta', 'categories': [{'measurements': [{'value': '169', 'groupId': 'OG000', 'lowerLimit': '124', 'upperLimit': '219'}, {'value': '141.5', 'groupId': 'OG001', 'lowerLimit': '123', 'upperLimit': '188'}]}]}, {'title': 'MIP-3 alpha', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000', 'lowerLimit': '17', 'upperLimit': '28'}, {'value': '21', 'groupId': 'OG001', 'lowerLimit': '14', 'upperLimit': '28'}]}]}, {'title': 'MPIF-1', 'categories': [{'measurements': [{'value': '1700', 'groupId': 'OG000', 'lowerLimit': '1200', 'upperLimit': '1900'}, {'value': '1500', 'groupId': 'OG001', 'lowerLimit': '1100', 'upperLimit': '1700'}]}]}, {'title': 'TNF-alpha', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000', 'lowerLimit': '13', 'upperLimit': '13'}, {'value': '13', 'groupId': 'OG001', 'lowerLimit': '13', 'upperLimit': '13'}]}]}, {'title': 'TNF-beta', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '3'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Post-placebo at Day -29', 'description': 'Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).'}, {'type': 'PRIMARY', 'title': 'Cytokines and Chemokines Concetrations During Step 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HBsAg/AS_1 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}, {'id': 'OG001', 'title': 'Engerix-B_1 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}], 'classes': [{'title': 'E-selectin', 'categories': [{'measurements': [{'value': '5900', 'groupId': 'OG000', 'lowerLimit': '3700', 'upperLimit': '7800'}, {'value': '6250', 'groupId': 'OG001', 'lowerLimit': '4300', 'upperLimit': '7900'}]}]}, {'title': 'GM-CSF', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000', 'lowerLimit': '14', 'upperLimit': '14'}, {'value': '14', 'groupId': 'OG001', 'lowerLimit': '14', 'upperLimit': '14'}]}]}, {'title': 'IFN-γ', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '1.6'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '1.6'}]}]}, {'title': 'IL-10', 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000', 'lowerLimit': '3.3', 'upperLimit': '3.9'}, {'value': '3.3', 'groupId': 'OG001', 'lowerLimit': '3.3', 'upperLimit': '3.9'}]}]}, {'title': 'IL-18', 'categories': [{'measurements': [{'value': '182', 'groupId': 'OG000', 'lowerLimit': '148', 'upperLimit': '288'}, {'value': '178.5', 'groupId': 'OG001', 'lowerLimit': '120', 'upperLimit': '232'}]}]}, {'title': 'IL-2', 'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000', 'lowerLimit': '5.9', 'upperLimit': '5.9'}, {'value': '5.9', 'groupId': 'OG001', 'lowerLimit': '5.9', 'upperLimit': '5.9'}]}]}, {'title': 'IL-3', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '1.6'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '1.6'}]}]}, {'title': 'IL-4', 'categories': [{'measurements': [{'value': '9.4', 'groupId': 'OG000', 'lowerLimit': '9.4', 'upperLimit': '9.4'}, {'value': '9.4', 'groupId': 'OG001', 'lowerLimit': '9.4', 'upperLimit': '9.4'}]}]}, {'title': 'IL-5', 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000', 'lowerLimit': '2.7', 'upperLimit': '2.7'}, {'value': '2.7', 'groupId': 'OG001', 'lowerLimit': '2.7', 'upperLimit': '2.7'}]}]}, {'title': 'IL-6', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '1.6'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '1.6'}]}]}, {'title': 'IL-6r', 'categories': [{'measurements': [{'value': '27000', 'groupId': 'OG000', 'lowerLimit': '20000', 'upperLimit': '35000'}, {'value': '25500', 'groupId': 'OG001', 'lowerLimit': '20000', 'upperLimit': '28000'}]}]}, {'title': 'IL-7', 'categories': [{'measurements': [{'value': '8.2', 'groupId': 'OG000', 'lowerLimit': '8.2', 'upperLimit': '8.2'}, {'value': '8.2', 'groupId': 'OG001', 'lowerLimit': '8.2', 'upperLimit': '8.2'}]}]}, {'title': 'IL-8', 'categories': [{'measurements': [{'value': '4.8', 'groupId': 'OG000', 'lowerLimit': '3.7', 'upperLimit': '6.5'}, {'value': '4.9', 'groupId': 'OG001', 'lowerLimit': '3.5', 'upperLimit': '6.6'}]}]}, {'title': 'IP-10', 'categories': [{'measurements': [{'value': '270', 'groupId': 'OG000', 'lowerLimit': '205', 'upperLimit': '381'}, {'value': '228', 'groupId': 'OG001', 'lowerLimit': '186', 'upperLimit': '304'}]}]}, {'title': 'MCP-1', 'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000', 'lowerLimit': '56', 'upperLimit': '112'}, {'value': '73.5', 'groupId': 'OG001', 'lowerLimit': '47', 'upperLimit': '90'}]}]}, {'title': 'MCP-2', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000', 'lowerLimit': '13', 'upperLimit': '26'}, {'value': '18.5', 'groupId': 'OG001', 'lowerLimit': '15', 'upperLimit': '26'}]}]}, {'title': 'MCP-4', 'categories': [{'measurements': [{'value': '1200', 'groupId': 'OG000', 'lowerLimit': '937', 'upperLimit': '1530'}, {'value': '1140', 'groupId': 'OG001', 'lowerLimit': '951', 'upperLimit': '1340'}]}]}, {'title': 'MIG', 'categories': [{'measurements': [{'value': '468', 'groupId': 'OG000', 'lowerLimit': '336', 'upperLimit': '568'}, {'value': '397', 'groupId': 'OG001', 'lowerLimit': '292', 'upperLimit': '587'}]}]}, {'title': 'MIP-1 alpha', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000', 'lowerLimit': '18', 'upperLimit': '21'}, {'value': '18', 'groupId': 'OG001', 'lowerLimit': '18', 'upperLimit': '18'}]}]}, {'title': 'MIP-1 beta', 'categories': [{'measurements': [{'value': '174', 'groupId': 'OG000', 'lowerLimit': '141', 'upperLimit': '227'}, {'value': '151.5', 'groupId': 'OG001', 'lowerLimit': '113', 'upperLimit': '175'}]}]}, {'title': 'MIP-3 alpha', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000', 'lowerLimit': '15', 'upperLimit': '28'}, {'value': '17.5', 'groupId': 'OG001', 'lowerLimit': '11', 'upperLimit': '33'}]}]}, {'title': 'MPIF-1', 'categories': [{'measurements': [{'value': '1500', 'groupId': 'OG000', 'lowerLimit': '1200', 'upperLimit': '1800'}, {'value': '1350', 'groupId': 'OG001', 'lowerLimit': '970', 'upperLimit': '1600'}]}]}, {'title': 'TNF-alpha', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000', 'lowerLimit': '13', 'upperLimit': '13'}, {'value': '13', 'groupId': 'OG001', 'lowerLimit': '13', 'upperLimit': '13'}]}]}, {'title': 'TNF-beta', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '3'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Post-placebo at Day -28', 'description': 'Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).'}, {'type': 'PRIMARY', 'title': 'Cytokines/Chemokines Concentrations in Step 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HBsAg/AS_1 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}, {'id': 'OG001', 'title': 'Engerix-B_1 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}], 'classes': [{'title': 'E-selectin', 'categories': [{'measurements': [{'value': '6150', 'groupId': 'OG000', 'lowerLimit': '3700', 'upperLimit': '8200'}, {'value': '6250', 'groupId': 'OG001', 'lowerLimit': '4000', 'upperLimit': '7200'}]}]}, {'title': 'GM-CSF', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000', 'lowerLimit': '14', 'upperLimit': '14'}, {'value': '14', 'groupId': 'OG001', 'lowerLimit': '14', 'upperLimit': '14'}]}]}, {'title': 'IFN-γ', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '1.6'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '1.6'}]}]}, {'title': 'IL-10', 'categories': [{'measurements': [{'value': '3.4', 'groupId': 'OG000', 'lowerLimit': '3.3', 'upperLimit': '4.5'}, {'value': '3.3', 'groupId': 'OG001', 'lowerLimit': '3.3', 'upperLimit': '4.2'}]}]}, {'title': 'IL-18', 'categories': [{'measurements': [{'value': '183', 'groupId': 'OG000', 'lowerLimit': '157', 'upperLimit': '236'}, {'value': '174.5', 'groupId': 'OG001', 'lowerLimit': '139', 'upperLimit': '217'}]}]}, {'title': 'IL-2', 'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000', 'lowerLimit': '5.9', 'upperLimit': '5.9'}, {'value': '5.9', 'groupId': 'OG001', 'lowerLimit': '5.9', 'upperLimit': '5.9'}]}]}, {'title': 'IL-3', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '1.6'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '1.6'}]}]}, {'title': 'IL-4', 'categories': [{'measurements': [{'value': '9.4', 'groupId': 'OG000', 'lowerLimit': '9.4', 'upperLimit': '9.4'}, {'value': '9.4', 'groupId': 'OG001', 'lowerLimit': '9.4', 'upperLimit': '9.4'}]}]}, {'title': 'IL-5', 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000', 'lowerLimit': '2.7', 'upperLimit': '2.7'}, {'value': '2.7', 'groupId': 'OG001', 'lowerLimit': '2.7', 'upperLimit': '2.7'}]}]}, {'title': 'IL-6', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '1.7'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '1.7'}]}]}, {'title': 'IL-6r', 'categories': [{'measurements': [{'value': '26000', 'groupId': 'OG000', 'lowerLimit': '21000', 'upperLimit': '32000'}, {'value': '24000', 'groupId': 'OG001', 'lowerLimit': '21000', 'upperLimit': '29000'}]}]}, {'title': 'IL-7', 'categories': [{'measurements': [{'value': '8.2', 'groupId': 'OG000', 'lowerLimit': '8.2', 'upperLimit': '8.2'}, {'value': '8.2', 'groupId': 'OG001', 'lowerLimit': '8.2', 'upperLimit': '8.2'}]}]}, {'title': 'IL-8', 'categories': [{'measurements': [{'value': '4.3', 'groupId': 'OG000', 'lowerLimit': '3.4', 'upperLimit': '6.6'}, {'value': '4.2', 'groupId': 'OG001', 'lowerLimit': '3.6', 'upperLimit': '5.4'}]}]}, {'title': 'IP-10', 'categories': [{'measurements': [{'value': '239', 'groupId': 'OG000', 'lowerLimit': '189', 'upperLimit': '348'}, {'value': '220.5', 'groupId': 'OG001', 'lowerLimit': '186', 'upperLimit': '281'}]}]}, {'title': 'MCP-1', 'categories': [{'measurements': [{'value': '84.5', 'groupId': 'OG000', 'lowerLimit': '65', 'upperLimit': '110'}, {'value': '86.5', 'groupId': 'OG001', 'lowerLimit': '73', 'upperLimit': '109'}]}]}, {'title': 'MCP-2', 'categories': [{'measurements': [{'value': '18.5', 'groupId': 'OG000', 'lowerLimit': '14', 'upperLimit': '22'}, {'value': '20', 'groupId': 'OG001', 'lowerLimit': '15', 'upperLimit': '25'}]}]}, {'title': 'MCP-4', 'categories': [{'measurements': [{'value': '1150', 'groupId': 'OG000', 'lowerLimit': '989', 'upperLimit': '1270'}, {'value': '1060', 'groupId': 'OG001', 'lowerLimit': '911', 'upperLimit': '1360'}]}]}, {'title': 'MIG', 'categories': [{'measurements': [{'value': '429.5', 'groupId': 'OG000', 'lowerLimit': '349', 'upperLimit': '542'}, {'value': '403.5', 'groupId': 'OG001', 'lowerLimit': '300', 'upperLimit': '635'}]}]}, {'title': 'MIP-1 alpha', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000', 'lowerLimit': '18', 'upperLimit': '23'}, {'value': '18', 'groupId': 'OG001', 'lowerLimit': '18', 'upperLimit': '19'}]}]}, {'title': 'MIP-1 beta', 'categories': [{'measurements': [{'value': '165', 'groupId': 'OG000', 'lowerLimit': '117', 'upperLimit': '196'}, {'value': '141', 'groupId': 'OG001', 'lowerLimit': '106', 'upperLimit': '181'}]}]}, {'title': 'MIP-3 alpha', 'categories': [{'measurements': [{'value': '20.5', 'groupId': 'OG000', 'lowerLimit': '18', 'upperLimit': '27'}, {'value': '21', 'groupId': 'OG001', 'lowerLimit': '18', 'upperLimit': '26'}]}]}, {'title': 'MPIF-1', 'categories': [{'measurements': [{'value': '1350', 'groupId': 'OG000', 'lowerLimit': '1200', 'upperLimit': '1700'}, {'value': '1300', 'groupId': 'OG001', 'lowerLimit': '1100', 'upperLimit': '1600'}]}]}, {'title': 'TNF-alpha', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000', 'lowerLimit': '13', 'upperLimit': '13'}, {'value': '13', 'groupId': 'OG001', 'lowerLimit': '13', 'upperLimit': '13'}]}]}, {'title': 'TNF-beta', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '3'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Post-placebo at Day -27', 'description': 'Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).'}, {'type': 'PRIMARY', 'title': 'Cytokines and Chemokines Concentrations During Step 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HBsAg/AS_1 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}, {'id': 'OG001', 'title': 'Engerix-B_1 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}], 'classes': [{'title': 'E-selectin', 'categories': [{'measurements': [{'value': '5500', 'groupId': 'OG000', 'lowerLimit': '4000', 'upperLimit': '8300'}, {'value': '6150', 'groupId': 'OG001', 'lowerLimit': '4700', 'upperLimit': '7900'}]}]}, {'title': 'GM-CSF', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000', 'lowerLimit': '14', 'upperLimit': '14'}, {'value': '14', 'groupId': 'OG001', 'lowerLimit': '14', 'upperLimit': '14'}]}]}, {'title': 'IFN-γ', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '1.6'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '1.6'}]}]}, {'title': 'IL-10', 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000', 'lowerLimit': '3.3', 'upperLimit': '4.3'}, {'value': '3.3', 'groupId': 'OG001', 'lowerLimit': '3.3', 'upperLimit': '3.5'}]}]}, {'title': 'IL-18', 'categories': [{'measurements': [{'value': '184', 'groupId': 'OG000', 'lowerLimit': '150', 'upperLimit': '247'}, {'value': '176.5', 'groupId': 'OG001', 'lowerLimit': '122', 'upperLimit': '208'}]}]}, {'title': 'IL-2', 'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000', 'lowerLimit': '5.9', 'upperLimit': '7'}, {'value': '5.9', 'groupId': 'OG001', 'lowerLimit': '5.9', 'upperLimit': '7'}]}]}, {'title': 'IL-3', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '1.6'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '1.6'}]}]}, {'title': 'IL-4', 'categories': [{'measurements': [{'value': '9.4', 'groupId': 'OG000', 'lowerLimit': '9.4', 'upperLimit': '9.4'}, {'value': '9.4', 'groupId': 'OG001', 'lowerLimit': '9.4', 'upperLimit': '9.4'}]}]}, {'title': 'IL-5', 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000', 'lowerLimit': '2.7', 'upperLimit': '2.7'}, {'value': '2.7', 'groupId': 'OG001', 'lowerLimit': '2.7', 'upperLimit': '2.7'}]}]}, {'title': 'IL-6', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '1.6'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '1.6'}]}]}, {'title': 'IL-6r', 'categories': [{'measurements': [{'value': '27000', 'groupId': 'OG000', 'lowerLimit': '17000', 'upperLimit': '310000'}, {'value': '23500', 'groupId': 'OG001', 'lowerLimit': '19000', 'upperLimit': '28000'}]}]}, {'title': 'IL-7', 'categories': [{'measurements': [{'value': '8.2', 'groupId': 'OG000', 'lowerLimit': '8.2', 'upperLimit': '8.2'}, {'value': '8.2', 'groupId': 'OG001', 'lowerLimit': '8.2', 'upperLimit': '8.2'}]}]}, {'title': 'IL-8', 'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000', 'lowerLimit': '3.9', 'upperLimit': '6.8'}, {'value': '5', 'groupId': 'OG001', 'lowerLimit': '3.5', 'upperLimit': '5.8'}]}]}, {'title': 'IP-10', 'categories': [{'measurements': [{'value': '241', 'groupId': 'OG000', 'lowerLimit': '190', 'upperLimit': '366'}, {'value': '223', 'groupId': 'OG001', 'lowerLimit': '186', 'upperLimit': '285'}]}]}, {'title': 'MCP-1', 'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000', 'lowerLimit': '55', 'upperLimit': '143'}, {'value': '72', 'groupId': 'OG001', 'lowerLimit': '66', 'upperLimit': '96'}]}]}, {'title': 'MCP-2', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000', 'lowerLimit': '14', 'upperLimit': '25'}, {'value': '19', 'groupId': 'OG001', 'lowerLimit': '16', 'upperLimit': '23'}]}]}, {'title': 'MCP-4', 'categories': [{'measurements': [{'value': '1390', 'groupId': 'OG000', 'lowerLimit': '1000', 'upperLimit': '1480'}, {'value': '1145', 'groupId': 'OG001', 'lowerLimit': '1000', 'upperLimit': '1350'}]}]}, {'title': 'MIG', 'categories': [{'measurements': [{'value': '391', 'groupId': 'OG000', 'lowerLimit': '337', 'upperLimit': '524'}, {'value': '375.5', 'groupId': 'OG001', 'lowerLimit': '286', 'upperLimit': '625'}]}]}, {'title': 'MIP-1 alpha', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000', 'lowerLimit': '18', 'upperLimit': '22'}, {'value': '18', 'groupId': 'OG001', 'lowerLimit': '18', 'upperLimit': '19'}]}]}, {'title': 'MIP-1 beta', 'categories': [{'measurements': [{'value': '165', 'groupId': 'OG000', 'lowerLimit': '128', 'upperLimit': '199'}, {'value': '138.5', 'groupId': 'OG001', 'lowerLimit': '113', 'upperLimit': '158'}]}]}, {'title': 'MIP-3 alpha', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000', 'lowerLimit': '13', 'upperLimit': '28'}, {'value': '16', 'groupId': 'OG001', 'lowerLimit': '10', 'upperLimit': '21'}]}]}, {'title': 'MPIF-1', 'categories': [{'measurements': [{'value': '1600', 'groupId': 'OG000', 'lowerLimit': '1200', 'upperLimit': '1800'}, {'value': '1350', 'groupId': 'OG001', 'lowerLimit': '1000', 'upperLimit': '1700'}]}]}, {'title': 'TNF-alpha', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000', 'lowerLimit': '13', 'upperLimit': '13'}, {'value': '13', 'groupId': 'OG001', 'lowerLimit': '13', 'upperLimit': '13'}]}]}, {'title': 'TNF-beta', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '3'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Post-placebo at Day -23', 'description': 'Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).'}, {'type': 'PRIMARY', 'title': 'Concentrations of Cytokines and Chemokines - Study Step 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HBsAg/AS_1 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}, {'id': 'OG001', 'title': 'Engerix-B_1 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}], 'classes': [{'title': 'E-selectin', 'categories': [{'measurements': [{'value': '6100', 'groupId': 'OG000', 'lowerLimit': '4200', 'upperLimit': '9000'}, {'value': '6150', 'groupId': 'OG001', 'lowerLimit': '5000', 'upperLimit': '8600'}]}]}, {'title': 'GM-CSF', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000', 'lowerLimit': '14', 'upperLimit': '14'}, {'value': '14', 'groupId': 'OG001', 'lowerLimit': '14', 'upperLimit': '14'}]}]}, {'title': 'IFN-γ', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '1.6'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '1.6'}]}]}, {'title': 'IL-10', 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000', 'lowerLimit': '3.3', 'upperLimit': '3.5'}, {'value': '3.3', 'groupId': 'OG001', 'lowerLimit': '3.3', 'upperLimit': '3.9'}]}]}, {'title': 'IL-18', 'categories': [{'measurements': [{'value': '169', 'groupId': 'OG000', 'lowerLimit': '151', 'upperLimit': '237'}, {'value': '171', 'groupId': 'OG001', 'lowerLimit': '119', 'upperLimit': '207'}]}]}, {'title': 'IL-2', 'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000', 'lowerLimit': '5.9', 'upperLimit': '6.5'}, {'value': '5.9', 'groupId': 'OG001', 'lowerLimit': '5.9', 'upperLimit': '6.5'}]}]}, {'title': 'IL-3', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '1.6'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '1.6'}]}]}, {'title': 'IL-4', 'categories': [{'measurements': [{'value': '9.4', 'groupId': 'OG000', 'lowerLimit': '9.4', 'upperLimit': '9.4'}, {'value': '9.4', 'groupId': 'OG001', 'lowerLimit': '9.4', 'upperLimit': '9.4'}]}]}, {'title': 'IL-5', 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000', 'lowerLimit': '2.7', 'upperLimit': '2.7'}, {'value': '2.7', 'groupId': 'OG001', 'lowerLimit': '2.7', 'upperLimit': '2.7'}]}]}, {'title': 'IL-6', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '1.6'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '1.6'}]}]}, {'title': 'IL-6r', 'categories': [{'measurements': [{'value': '27000', 'groupId': 'OG000', 'lowerLimit': '20000', 'upperLimit': '32000'}, {'value': '24500', 'groupId': 'OG001', 'lowerLimit': '22000', 'upperLimit': '29000'}]}]}, {'title': 'IL-7', 'categories': [{'measurements': [{'value': '8.2', 'groupId': 'OG000', 'lowerLimit': '8.2', 'upperLimit': '8.2'}, {'value': '8.2', 'groupId': 'OG001', 'lowerLimit': '8.2', 'upperLimit': '8.2'}]}]}, {'title': 'IL-8', 'categories': [{'measurements': [{'value': '4.9', 'groupId': 'OG000', 'lowerLimit': '4.2', 'upperLimit': '6.2'}, {'value': '5', 'groupId': 'OG001', 'lowerLimit': '4.2', 'upperLimit': '7.4'}]}]}, {'title': 'IP-10', 'categories': [{'measurements': [{'value': '243', 'groupId': 'OG000', 'lowerLimit': '199', 'upperLimit': '294'}, {'value': '225', 'groupId': 'OG001', 'lowerLimit': '178', 'upperLimit': '334'}]}]}, {'title': 'MCP-1', 'categories': [{'measurements': [{'value': '94', 'groupId': 'OG000', 'lowerLimit': '75', 'upperLimit': '121'}, {'value': '92.5', 'groupId': 'OG001', 'lowerLimit': '80', 'upperLimit': '125'}]}]}, {'title': 'MCP-2', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000', 'lowerLimit': '14', 'upperLimit': '22'}, {'value': '19', 'groupId': 'OG001', 'lowerLimit': '16', 'upperLimit': '28'}]}]}, {'title': 'MCP-4', 'categories': [{'measurements': [{'value': '1310', 'groupId': 'OG000', 'lowerLimit': '1110', 'upperLimit': '1570'}, {'value': '1260', 'groupId': 'OG001', 'lowerLimit': '1030', 'upperLimit': '1520'}]}]}, {'title': 'MIG', 'categories': [{'measurements': [{'value': '496', 'groupId': 'OG000', 'lowerLimit': '328', 'upperLimit': '705'}, {'value': '462.5', 'groupId': 'OG001', 'lowerLimit': '303', 'upperLimit': '701'}]}]}, {'title': 'MIP-1 alpha', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000', 'lowerLimit': '18', 'upperLimit': '23'}, {'value': '18', 'groupId': 'OG001', 'lowerLimit': '18', 'upperLimit': '19'}]}]}, {'title': 'MIP-1 beta', 'categories': [{'measurements': [{'value': '164', 'groupId': 'OG000', 'lowerLimit': '121', 'upperLimit': '198'}, {'value': '153', 'groupId': 'OG001', 'lowerLimit': '124', 'upperLimit': '196'}]}]}, {'title': 'MIP-3 alpha', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000', 'lowerLimit': '11', 'upperLimit': '27'}, {'value': '19.5', 'groupId': 'OG001', 'lowerLimit': '14', 'upperLimit': '24'}]}]}, {'title': 'MPIF-1', 'categories': [{'measurements': [{'value': '1500', 'groupId': 'OG000', 'lowerLimit': '1300', 'upperLimit': '1700'}, {'value': '1300', 'groupId': 'OG001', 'lowerLimit': '1000', 'upperLimit': '1500'}]}]}, {'title': 'TNF-alpha', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000', 'lowerLimit': '13', 'upperLimit': '13'}, {'value': '13', 'groupId': 'OG001', 'lowerLimit': '13', 'upperLimit': '13'}]}]}, {'title': 'TNF-beta', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '3'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-dose1 at Day 0', 'description': 'Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).'}, {'type': 'PRIMARY', 'title': 'Concentrations of Cytokines and Chemokines in Step 1 of Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HBsAg/AS_1 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}, {'id': 'OG001', 'title': 'Engerix-B_1 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}], 'classes': [{'title': 'E-selectin', 'categories': [{'measurements': [{'value': '5500', 'groupId': 'OG000', 'lowerLimit': '4000', 'upperLimit': '8400'}, {'value': '5900', 'groupId': 'OG001', 'lowerLimit': '4800', 'upperLimit': '8100'}]}]}, {'title': 'GM-CSF', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000', 'lowerLimit': '14', 'upperLimit': '14'}, {'value': '14', 'groupId': 'OG001', 'lowerLimit': '14', 'upperLimit': '14'}]}]}, {'title': 'IFN-γ', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '1.6'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '1.6'}]}]}, {'title': 'IL-10', 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000', 'lowerLimit': '3.3', 'upperLimit': '3.8'}, {'value': '3.3', 'groupId': 'OG001', 'lowerLimit': '3.3', 'upperLimit': '3.9'}]}]}, {'title': 'IL-18', 'categories': [{'measurements': [{'value': '168', 'groupId': 'OG000', 'lowerLimit': '144', 'upperLimit': '220'}, {'value': '168', 'groupId': 'OG001', 'lowerLimit': '126', 'upperLimit': '208'}]}]}, {'title': 'IL-2', 'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000', 'lowerLimit': '5.9', 'upperLimit': '5.9'}, {'value': '5.9', 'groupId': 'OG001', 'lowerLimit': '5.9', 'upperLimit': '7.4'}]}]}, {'title': 'IL-3', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '1.6'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '1.6'}]}]}, {'title': 'IL-4', 'categories': [{'measurements': [{'value': '9.4', 'groupId': 'OG000', 'lowerLimit': '9.4', 'upperLimit': '9.4'}, {'value': '9.4', 'groupId': 'OG001', 'lowerLimit': '9.4', 'upperLimit': '9.4'}]}]}, {'title': 'IL-5', 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000', 'lowerLimit': '2.7', 'upperLimit': '2.7'}, {'value': '2.7', 'groupId': 'OG001', 'lowerLimit': '2.7', 'upperLimit': '2.7'}]}]}, {'title': 'IL-6', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '1.6'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '1.6'}]}]}, {'title': 'IL-6r', 'categories': [{'measurements': [{'value': '26000', 'groupId': 'OG000', 'lowerLimit': '21000', 'upperLimit': '32000'}, {'value': '25000', 'groupId': 'OG001', 'lowerLimit': '19000', 'upperLimit': '29000'}]}]}, {'title': 'IL-7', 'categories': [{'measurements': [{'value': '8.2', 'groupId': 'OG000', 'lowerLimit': '8.2', 'upperLimit': '8.2'}, {'value': '8.2', 'groupId': 'OG001', 'lowerLimit': '8.2', 'upperLimit': '8.2'}]}]}, {'title': 'IL-8', 'categories': [{'measurements': [{'value': '4.9', 'groupId': 'OG000', 'lowerLimit': '3.6', 'upperLimit': '5.5'}, {'value': '4.2', 'groupId': 'OG001', 'lowerLimit': '3.3', 'upperLimit': '5.1'}]}]}, {'title': 'IP-10', 'categories': [{'measurements': [{'value': '224', 'groupId': 'OG000', 'lowerLimit': '198', 'upperLimit': '318'}, {'value': '226', 'groupId': 'OG001', 'lowerLimit': '186', 'upperLimit': '265'}]}]}, {'title': 'MCP-1', 'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000', 'lowerLimit': '56', 'upperLimit': '97'}, {'value': '75', 'groupId': 'OG001', 'lowerLimit': '56', 'upperLimit': '108'}]}]}, {'title': 'MCP-2', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000', 'lowerLimit': '14', 'upperLimit': '23'}, {'value': '20', 'groupId': 'OG001', 'lowerLimit': '16', 'upperLimit': '22'}]}]}, {'title': 'MCP-4', 'categories': [{'measurements': [{'value': '1240', 'groupId': 'OG000', 'lowerLimit': '943', 'upperLimit': '1520'}, {'value': '1240', 'groupId': 'OG001', 'lowerLimit': '951', 'upperLimit': '1340'}]}]}, {'title': 'MIG', 'categories': [{'measurements': [{'value': '423', 'groupId': 'OG000', 'lowerLimit': '385', 'upperLimit': '535'}, {'value': '378', 'groupId': 'OG001', 'lowerLimit': '308', 'upperLimit': '522'}]}]}, {'title': 'MIP-1 alpha', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000', 'lowerLimit': '18', 'upperLimit': '22'}, {'value': '18', 'groupId': 'OG001', 'lowerLimit': '18', 'upperLimit': '19'}]}]}, {'title': 'MIP-1 beta', 'categories': [{'measurements': [{'value': '164', 'groupId': 'OG000', 'lowerLimit': '132', 'upperLimit': '194'}, {'value': '137', 'groupId': 'OG001', 'lowerLimit': '114', 'upperLimit': '167'}]}]}, {'title': 'MIP-3 alpha', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000', 'lowerLimit': '15', 'upperLimit': '26'}, {'value': '20', 'groupId': 'OG001', 'lowerLimit': '14', 'upperLimit': '24'}]}]}, {'title': 'MPIF-1', 'categories': [{'measurements': [{'value': '1500', 'groupId': 'OG000', 'lowerLimit': '1300', 'upperLimit': '1800'}, {'value': '1200', 'groupId': 'OG001', 'lowerLimit': '970', 'upperLimit': '1400'}]}]}, {'title': 'TNF-alpha', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000', 'lowerLimit': '13', 'upperLimit': '13'}, {'value': '13', 'groupId': 'OG001', 'lowerLimit': '13', 'upperLimit': '13'}]}]}, {'title': 'TNF-beta', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '3'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Post-dose1 at Day 0 plus 1.5 Hours', 'description': 'Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).'}, {'type': 'PRIMARY', 'title': 'Concentrations of Cytokines and Chemokines During Step 1 of Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HBsAg/AS_1 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}, {'id': 'OG001', 'title': 'Engerix-B_1 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}], 'classes': [{'title': 'E-selectin', 'categories': [{'measurements': [{'value': '5400', 'groupId': 'OG000', 'lowerLimit': '4100', 'upperLimit': '7600'}, {'value': '5900', 'groupId': 'OG001', 'lowerLimit': '4300', 'upperLimit': '7600'}]}]}, {'title': 'GM-CSF', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000', 'lowerLimit': '14', 'upperLimit': '14'}, {'value': '14', 'groupId': 'OG001', 'lowerLimit': '14', 'upperLimit': '14'}]}]}, {'title': 'IFN-γ', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '1.6'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '1.6'}]}]}, {'title': 'IL-10', 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000', 'lowerLimit': '3.3', 'upperLimit': '3.3'}, {'value': '3.3', 'groupId': 'OG001', 'lowerLimit': '3.3', 'upperLimit': '3.3'}]}]}, {'title': 'IL-18', 'categories': [{'measurements': [{'value': '170', 'groupId': 'OG000', 'lowerLimit': '130', 'upperLimit': '225'}, {'value': '169', 'groupId': 'OG001', 'lowerLimit': '110', 'upperLimit': '220'}]}]}, {'title': 'IL-2', 'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000', 'lowerLimit': '5.9', 'upperLimit': '6'}, {'value': '5.9', 'groupId': 'OG001', 'lowerLimit': '5.9', 'upperLimit': '6'}]}]}, {'title': 'IL-3', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '1.6'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '1.6'}]}]}, {'title': 'IL-4', 'categories': [{'measurements': [{'value': '9.4', 'groupId': 'OG000', 'lowerLimit': '9.4', 'upperLimit': '9.4'}, {'value': '9.4', 'groupId': 'OG001', 'lowerLimit': '9.4', 'upperLimit': '9.4'}]}]}, {'title': 'IL-5', 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000', 'lowerLimit': '2.7', 'upperLimit': '2.7'}, {'value': '2.7', 'groupId': 'OG001', 'lowerLimit': '2.7', 'upperLimit': '2.7'}]}]}, {'title': 'IL-6', 'categories': [{'measurements': [{'value': '3.4', 'groupId': 'OG000', 'lowerLimit': '2.4', 'upperLimit': '6'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '1.7'}]}]}, {'title': 'IL-6r', 'categories': [{'measurements': [{'value': '26000', 'groupId': 'OG000', 'lowerLimit': '20000', 'upperLimit': '33000'}, {'value': '25000', 'groupId': 'OG001', 'lowerLimit': '22000', 'upperLimit': '30000'}]}]}, {'title': 'IL-7', 'categories': [{'measurements': [{'value': '8.2', 'groupId': 'OG000', 'lowerLimit': '8.2', 'upperLimit': '8.2'}, {'value': '8.2', 'groupId': 'OG001', 'lowerLimit': '8.2', 'upperLimit': '8.2'}]}]}, {'title': 'IL-8', 'categories': [{'measurements': [{'value': '4.6', 'groupId': 'OG000', 'lowerLimit': '3.9', 'upperLimit': '5.5'}, {'value': '4.6', 'groupId': 'OG001', 'lowerLimit': '3.9', 'upperLimit': '7.2'}]}]}, {'title': 'IP-10', 'categories': [{'measurements': [{'value': '207', 'groupId': 'OG000', 'lowerLimit': '179', 'upperLimit': '270'}, {'value': '204', 'groupId': 'OG001', 'lowerLimit': '180', 'upperLimit': '282'}]}]}, {'title': 'MCP-1', 'categories': [{'measurements': [{'value': '94', 'groupId': 'OG000', 'lowerLimit': '75', 'upperLimit': '123'}, {'value': '85', 'groupId': 'OG001', 'lowerLimit': '66', 'upperLimit': '112'}]}]}, {'title': 'MCP-2', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000', 'lowerLimit': '15', 'upperLimit': '20'}, {'value': '18.5', 'groupId': 'OG001', 'lowerLimit': '16', 'upperLimit': '23'}]}]}, {'title': 'MCP-4', 'categories': [{'measurements': [{'value': '1130', 'groupId': 'OG000', 'lowerLimit': '912', 'upperLimit': '1390'}, {'value': '1130', 'groupId': 'OG001', 'lowerLimit': '989', 'upperLimit': '1310'}]}]}, {'title': 'MIG', 'categories': [{'measurements': [{'value': '459', 'groupId': 'OG000', 'lowerLimit': '332', 'upperLimit': '567'}, {'value': '372.5', 'groupId': 'OG001', 'lowerLimit': '302', 'upperLimit': '557'}]}]}, {'title': 'MIP-1 alpha', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000', 'lowerLimit': '18', 'upperLimit': '21'}, {'value': '18', 'groupId': 'OG001', 'lowerLimit': '18', 'upperLimit': '19'}]}]}, {'title': 'MIP-1 beta', 'categories': [{'measurements': [{'value': '165', 'groupId': 'OG000', 'lowerLimit': '129', 'upperLimit': '181'}, {'value': '141', 'groupId': 'OG001', 'lowerLimit': '111', 'upperLimit': '174'}]}]}, {'title': 'MIP-3 alpha', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000', 'lowerLimit': '15', 'upperLimit': '28'}, {'value': '18.5', 'groupId': 'OG001', 'lowerLimit': '12', 'upperLimit': '23'}]}]}, {'title': 'MPIF-1', 'categories': [{'measurements': [{'value': '1400', 'groupId': 'OG000', 'lowerLimit': '1200', 'upperLimit': '1600'}, {'value': '1300', 'groupId': 'OG001', 'lowerLimit': '1000', 'upperLimit': '1500'}]}]}, {'title': 'TNF-alpha', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000', 'lowerLimit': '13', 'upperLimit': '13'}, {'value': '13', 'groupId': 'OG001', 'lowerLimit': '13', 'upperLimit': '13'}]}]}, {'title': 'TNF-beta', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '3'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Post-dose1 at Day 0 plus 6 Hours', 'description': 'Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).'}, {'type': 'PRIMARY', 'title': 'Cytokines and Chemokines Concentrations - Study Step 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HBsAg/AS_1 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}, {'id': 'OG001', 'title': 'Engerix-B_1 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}], 'classes': [{'title': 'E-selectin', 'categories': [{'measurements': [{'value': '5900', 'groupId': 'OG000', 'lowerLimit': '4400', 'upperLimit': '8800'}, {'value': '6400', 'groupId': 'OG001', 'lowerLimit': '5000', 'upperLimit': '8000'}]}]}, {'title': 'GM-CSF', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000', 'lowerLimit': '14', 'upperLimit': '14'}, {'value': '14', 'groupId': 'OG001', 'lowerLimit': '14', 'upperLimit': '14'}]}]}, {'title': 'IFN-γ', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '1.6'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '1.6'}]}]}, {'title': 'IL-10', 'categories': [{'measurements': [{'value': '3.9', 'groupId': 'OG000', 'lowerLimit': '3.3', 'upperLimit': '5.5'}, {'value': '3.3', 'groupId': 'OG001', 'lowerLimit': '3.3', 'upperLimit': '3.3'}]}]}, {'title': 'IL-18', 'categories': [{'measurements': [{'value': '171', 'groupId': 'OG000', 'lowerLimit': '155', 'upperLimit': '235'}, {'value': '181.5', 'groupId': 'OG001', 'lowerLimit': '128', 'upperLimit': '205'}]}]}, {'title': 'IL-2', 'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000', 'lowerLimit': '5.9', 'upperLimit': '6.5'}, {'value': '5.9', 'groupId': 'OG001', 'lowerLimit': '5.9', 'upperLimit': '6'}]}]}, {'title': 'IL-3', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '1.6'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '1.6'}]}]}, {'title': 'IL-4', 'categories': [{'measurements': [{'value': '9.4', 'groupId': 'OG000', 'lowerLimit': '9.4', 'upperLimit': '9.4'}, {'value': '9.4', 'groupId': 'OG001', 'lowerLimit': '9.4', 'upperLimit': '9.4'}]}]}, {'title': 'IL-5', 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000', 'lowerLimit': '2.7', 'upperLimit': '2.7'}, {'value': '2.7', 'groupId': 'OG001', 'lowerLimit': '2.7', 'upperLimit': '2.7'}]}]}, {'title': 'IL-6', 'categories': [{'measurements': [{'value': '6.3', 'groupId': 'OG000', 'lowerLimit': '3.9', 'upperLimit': '8.2'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '1.6'}]}]}, {'title': 'IL-6r', 'categories': [{'measurements': [{'value': '26000', 'groupId': 'OG000', 'lowerLimit': '21000', 'upperLimit': '32000'}, {'value': '24000', 'groupId': 'OG001', 'lowerLimit': '22000', 'upperLimit': '33000'}]}]}, {'title': 'IL-7', 'categories': [{'measurements': [{'value': '8.2', 'groupId': 'OG000', 'lowerLimit': '8.2', 'upperLimit': '8.2'}, {'value': '8.2', 'groupId': 'OG001', 'lowerLimit': '8.2', 'upperLimit': '8.2'}]}]}, {'title': 'IL-8', 'categories': [{'measurements': [{'value': '4.2', 'groupId': 'OG000', 'lowerLimit': '3.5', 'upperLimit': '5.1'}, {'value': '4.8', 'groupId': 'OG001', 'lowerLimit': '4', 'upperLimit': '5.6'}]}]}, {'title': 'IP-10', 'categories': [{'measurements': [{'value': '236', 'groupId': 'OG000', 'lowerLimit': '197', 'upperLimit': '281'}, {'value': '194', 'groupId': 'OG001', 'lowerLimit': '167', 'upperLimit': '282'}]}]}, {'title': 'MCP-1', 'categories': [{'measurements': [{'value': '111', 'groupId': 'OG000', 'lowerLimit': '87', 'upperLimit': '137'}, {'value': '111.5', 'groupId': 'OG001', 'lowerLimit': '84', 'upperLimit': '129'}]}]}, {'title': 'MCP-2', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000', 'lowerLimit': '15', 'upperLimit': '27'}, {'value': '19.5', 'groupId': 'OG001', 'lowerLimit': '15', 'upperLimit': '25'}]}]}, {'title': 'MCP-4', 'categories': [{'measurements': [{'value': '1260', 'groupId': 'OG000', 'lowerLimit': '1000', 'upperLimit': '1530'}, {'value': '1265', 'groupId': 'OG001', 'lowerLimit': '1030', 'upperLimit': '1520'}]}]}, {'title': 'MIG', 'categories': [{'measurements': [{'value': '478', 'groupId': 'OG000', 'lowerLimit': '361', 'upperLimit': '614'}, {'value': '410', 'groupId': 'OG001', 'lowerLimit': '296', 'upperLimit': '588'}]}]}, {'title': 'MIP-1 alpha', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000', 'lowerLimit': '18', 'upperLimit': '21'}, {'value': '18', 'groupId': 'OG001', 'lowerLimit': '18', 'upperLimit': '19'}]}]}, {'title': 'MIP-1 beta', 'categories': [{'measurements': [{'value': '183', 'groupId': 'OG000', 'lowerLimit': '142', 'upperLimit': '212'}, {'value': '132', 'groupId': 'OG001', 'lowerLimit': '102', 'upperLimit': '171'}]}]}, {'title': 'MIP-3 alpha', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000', 'lowerLimit': '17', 'upperLimit': '28'}, {'value': '19.5', 'groupId': 'OG001', 'lowerLimit': '14', 'upperLimit': '27'}]}]}, {'title': 'MPIF-1', 'categories': [{'measurements': [{'value': '1600', 'groupId': 'OG000', 'lowerLimit': '1200', 'upperLimit': '1700'}, {'value': '1300', 'groupId': 'OG001', 'lowerLimit': '1000', 'upperLimit': '1700'}]}]}, {'title': 'TNF-alpha', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000', 'lowerLimit': '13', 'upperLimit': '13'}, {'value': '13', 'groupId': 'OG001', 'lowerLimit': '13', 'upperLimit': '13'}]}]}, {'title': 'TNF-beta', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '3'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Post-dose1 at Day 0 plus 12 Hours', 'description': 'Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).'}, {'type': 'PRIMARY', 'title': 'Cytokines and Chemokines Concentrations in Step 1 of Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HBsAg/AS_1 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}, {'id': 'OG001', 'title': 'Engerix-B_1 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}], 'classes': [{'title': 'E-selectin', 'categories': [{'measurements': [{'value': '5750', 'groupId': 'OG000', 'lowerLimit': '3400', 'upperLimit': '8000'}, {'value': '4700', 'groupId': 'OG001', 'lowerLimit': '3500', 'upperLimit': '5900'}]}]}, {'title': 'GM-CSF', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000', 'lowerLimit': '14', 'upperLimit': '14'}, {'value': '14', 'groupId': 'OG001', 'lowerLimit': '14', 'upperLimit': '14'}]}]}, {'title': 'IFN-γ', 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '2.4'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '1.6'}]}]}, {'title': 'IL-10', 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000', 'lowerLimit': '3.3', 'upperLimit': '4.8'}, {'value': '3.3', 'groupId': 'OG001', 'lowerLimit': '3.3', 'upperLimit': '3.3'}]}]}, {'title': 'IL-18', 'categories': [{'measurements': [{'value': '180', 'groupId': 'OG000', 'lowerLimit': '155', 'upperLimit': '217'}, {'value': '126', 'groupId': 'OG001', 'lowerLimit': '93', 'upperLimit': '168'}]}]}, {'title': 'IL-2', 'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000', 'lowerLimit': '5.9', 'upperLimit': '6'}, {'value': '5.9', 'groupId': 'OG001', 'lowerLimit': '5.9', 'upperLimit': '6'}]}]}, {'title': 'IL-3', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '1.6'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '1.6'}]}]}, {'title': 'IL-4', 'categories': [{'measurements': [{'value': '9.4', 'groupId': 'OG000', 'lowerLimit': '9.4', 'upperLimit': '9.4'}, {'value': '9.4', 'groupId': 'OG001', 'lowerLimit': '9.4', 'upperLimit': '9.4'}]}]}, {'title': 'IL-5', 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000', 'lowerLimit': '2.7', 'upperLimit': '2.7'}, {'value': '2.7', 'groupId': 'OG001', 'lowerLimit': '2.7', 'upperLimit': '2.7'}]}]}, {'title': 'IL-6', 'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000', 'lowerLimit': '3.1', 'upperLimit': '6.9'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '1.6'}]}]}, {'title': 'IL-6r', 'categories': [{'measurements': [{'value': '22500', 'groupId': 'OG000', 'lowerLimit': '17000', 'upperLimit': '26000'}, {'value': '22000', 'groupId': 'OG001', 'lowerLimit': '19000', 'upperLimit': '31000'}]}]}, {'title': 'IL-7', 'categories': [{'measurements': [{'value': '8.2', 'groupId': 'OG000', 'lowerLimit': '8.2', 'upperLimit': '8.2'}, {'value': '8.2', 'groupId': 'OG001', 'lowerLimit': '8.2', 'upperLimit': '8.2'}]}]}, {'title': 'IL-8', 'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000', 'lowerLimit': '4.5', 'upperLimit': '6.4'}, {'value': '5.1', 'groupId': 'OG001', 'lowerLimit': '4.2', 'upperLimit': '6'}]}]}, {'title': 'IP-10', 'categories': [{'measurements': [{'value': '319', 'groupId': 'OG000', 'lowerLimit': '268', 'upperLimit': '477'}, {'value': '228', 'groupId': 'OG001', 'lowerLimit': '184', 'upperLimit': '258'}]}]}, {'title': 'MCP-1', 'categories': [{'measurements': [{'value': '111', 'groupId': 'OG000', 'lowerLimit': '91', 'upperLimit': '130'}, {'value': '115', 'groupId': 'OG001', 'lowerLimit': '98', 'upperLimit': '130'}]}]}, {'title': 'MCP-2', 'categories': [{'measurements': [{'value': '29.5', 'groupId': 'OG000', 'lowerLimit': '19', 'upperLimit': '34'}, {'value': '20', 'groupId': 'OG001', 'lowerLimit': '17', 'upperLimit': '22'}]}]}, {'title': 'MCP-4', 'categories': [{'measurements': [{'value': '1400', 'groupId': 'OG000', 'lowerLimit': '1310', 'upperLimit': '1650'}, {'value': '1400', 'groupId': 'OG001', 'lowerLimit': '1220', 'upperLimit': '1560'}]}]}, {'title': 'MIG', 'categories': [{'measurements': [{'value': '571', 'groupId': 'OG000', 'lowerLimit': '443', 'upperLimit': '684'}, {'value': '473', 'groupId': 'OG001', 'lowerLimit': '367', 'upperLimit': '722'}]}]}, {'title': 'MIP-1 alpha', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000', 'lowerLimit': '18', 'upperLimit': '20'}, {'value': '18', 'groupId': 'OG001', 'lowerLimit': '18', 'upperLimit': '18'}]}]}, {'title': 'MIP-1 beta', 'categories': [{'measurements': [{'value': '258', 'groupId': 'OG000', 'lowerLimit': '200', 'upperLimit': '303'}, {'value': '134', 'groupId': 'OG001', 'lowerLimit': '117', 'upperLimit': '206'}]}]}, {'title': 'MIP-3 alpha', 'categories': [{'measurements': [{'value': '35.5', 'groupId': 'OG000', 'lowerLimit': '24', 'upperLimit': '45'}, {'value': '20', 'groupId': 'OG001', 'lowerLimit': '17', 'upperLimit': '30'}]}]}, {'title': 'MPIF-1', 'categories': [{'measurements': [{'value': '1850', 'groupId': 'OG000', 'lowerLimit': '1500', 'upperLimit': '2100'}, {'value': '1400', 'groupId': 'OG001', 'lowerLimit': '1100', 'upperLimit': '1600'}]}]}, {'title': 'TNF-alpha', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000', 'lowerLimit': '13', 'upperLimit': '13'}, {'value': '13', 'groupId': 'OG001', 'lowerLimit': '13', 'upperLimit': '13'}]}]}, {'title': 'TNF-beta', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '3'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Post-dose1 at Day 0 plus 18 Hours', 'description': 'Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).'}, {'type': 'PRIMARY', 'title': 'Cytokines and Chemokines Concentrations During Step 1 of Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HBsAg/AS_1 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}, {'id': 'OG001', 'title': 'Engerix-B_1 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}], 'classes': [{'title': 'E-selectin', 'categories': [{'measurements': [{'value': '5950', 'groupId': 'OG000', 'lowerLimit': '4200', 'upperLimit': '9500'}, {'value': '6000', 'groupId': 'OG001', 'lowerLimit': '4900', 'upperLimit': '8900'}]}]}, {'title': 'GM-CSF', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000', 'lowerLimit': '14', 'upperLimit': '14'}, {'value': '14', 'groupId': 'OG001', 'lowerLimit': '14', 'upperLimit': '14'}]}]}, {'title': 'IFN-γ', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '1.6'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '1.6'}]}]}, {'title': 'IL-10', 'categories': [{'measurements': [{'value': '5.2', 'groupId': 'OG000', 'lowerLimit': '3.6', 'upperLimit': '6.8'}, {'value': '3.3', 'groupId': 'OG001', 'lowerLimit': '3.3', 'upperLimit': '3.6'}]}]}, {'title': 'IL-18', 'categories': [{'measurements': [{'value': '198.5', 'groupId': 'OG000', 'lowerLimit': '167', 'upperLimit': '267'}, {'value': '181', 'groupId': 'OG001', 'lowerLimit': '123', 'upperLimit': '200'}]}]}, {'title': 'IL-2', 'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000', 'lowerLimit': '5.9', 'upperLimit': '5.9'}, {'value': '5.9', 'groupId': 'OG001', 'lowerLimit': '5.9', 'upperLimit': '5.9'}]}]}, {'title': 'IL-3', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '1.6'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '1.6'}]}]}, {'title': 'IL-4', 'categories': [{'measurements': [{'value': '9.4', 'groupId': 'OG000', 'lowerLimit': '9.4', 'upperLimit': '9.4'}, {'value': '9.4', 'groupId': 'OG001', 'lowerLimit': '9.4', 'upperLimit': '9.4'}]}]}, {'title': 'IL-5', 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000', 'lowerLimit': '2.7', 'upperLimit': '2.7'}, {'value': '2.7', 'groupId': 'OG001', 'lowerLimit': '2.7', 'upperLimit': '2.7'}]}]}, {'title': 'IL-6', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '4.1'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '1.6'}]}]}, {'title': 'IL-6r', 'categories': [{'measurements': [{'value': '26500', 'groupId': 'OG000', 'lowerLimit': '22000', 'upperLimit': '35000'}, {'value': '24500', 'groupId': 'OG001', 'lowerLimit': '21500', 'upperLimit': '31000'}]}]}, {'title': 'IL-7', 'categories': [{'measurements': [{'value': '8.2', 'groupId': 'OG000', 'lowerLimit': '8.2', 'upperLimit': '8.2'}, {'value': '8.2', 'groupId': 'OG001', 'lowerLimit': '8.2', 'upperLimit': '8.2'}]}]}, {'title': 'IL-8', 'categories': [{'measurements': [{'value': '5.1', 'groupId': 'OG000', 'lowerLimit': '4.1', 'upperLimit': '6.3'}, {'value': '4.4', 'groupId': 'OG001', 'lowerLimit': '3.8', 'upperLimit': '5.6'}]}]}, {'title': 'IP-10', 'categories': [{'measurements': [{'value': '295', 'groupId': 'OG000', 'lowerLimit': '251', 'upperLimit': '414'}, {'value': '219', 'groupId': 'OG001', 'lowerLimit': '179', 'upperLimit': '326'}]}]}, {'title': 'MCP-1', 'categories': [{'measurements': [{'value': '85.5', 'groupId': 'OG000', 'lowerLimit': '67', 'upperLimit': '101'}, {'value': '92', 'groupId': 'OG001', 'lowerLimit': '73', 'upperLimit': '112'}]}]}, {'title': 'MCP-2', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000', 'lowerLimit': '16', 'upperLimit': '26'}, {'value': '20', 'groupId': 'OG001', 'lowerLimit': '17', 'upperLimit': '25'}]}]}, {'title': 'MCP-4', 'categories': [{'measurements': [{'value': '1360', 'groupId': 'OG000', 'lowerLimit': '1120', 'upperLimit': '1600'}, {'value': '1270', 'groupId': 'OG001', 'lowerLimit': '1100', 'upperLimit': '1630'}]}]}, {'title': 'MIG', 'categories': [{'measurements': [{'value': '526', 'groupId': 'OG000', 'lowerLimit': '441', 'upperLimit': '678'}, {'value': '425', 'groupId': 'OG001', 'lowerLimit': '299', 'upperLimit': '606'}]}]}, {'title': 'MIP-1 alpha', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000', 'lowerLimit': '18', 'upperLimit': '22'}, {'value': '18', 'groupId': 'OG001', 'lowerLimit': '18', 'upperLimit': '20'}]}]}, {'title': 'MIP-1 beta', 'categories': [{'measurements': [{'value': '282.5', 'groupId': 'OG000', 'lowerLimit': '234', 'upperLimit': '408'}, {'value': '145', 'groupId': 'OG001', 'lowerLimit': '130', 'upperLimit': '207'}]}]}, {'title': 'MIP-3 alpha', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000', 'lowerLimit': '14', 'upperLimit': '28'}, {'value': '16', 'groupId': 'OG001', 'lowerLimit': '12', 'upperLimit': '23'}]}]}, {'title': 'MPIF-1', 'categories': [{'measurements': [{'value': '2300', 'groupId': 'OG000', 'lowerLimit': '2000', 'upperLimit': '2600'}, {'value': '1400', 'groupId': 'OG001', 'lowerLimit': '1200', 'upperLimit': '1800'}]}]}, {'title': 'TNF-alpha', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000', 'lowerLimit': '13', 'upperLimit': '13'}, {'value': '13', 'groupId': 'OG001', 'lowerLimit': '13', 'upperLimit': '13'}]}]}, {'title': 'TNF-beta', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '3'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Post-dose1 at Day 1', 'description': 'Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).'}, {'type': 'PRIMARY', 'title': 'Cytokines/Chemokines Concentrations - Study Step 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HBsAg/AS_1 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}, {'id': 'OG001', 'title': 'Engerix-B_1 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}], 'classes': [{'title': 'E-selectin', 'categories': [{'measurements': [{'value': '5800', 'groupId': 'OG000', 'lowerLimit': '4300', 'upperLimit': '9300'}, {'value': '6300', 'groupId': 'OG001', 'lowerLimit': '5000', 'upperLimit': '7400'}]}]}, {'title': 'GM-CSF', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000', 'lowerLimit': '14', 'upperLimit': '14'}, {'value': '14', 'groupId': 'OG001', 'lowerLimit': '14', 'upperLimit': '14'}]}]}, {'title': 'IFN-γ', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '1.6'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '1.6'}]}]}, {'title': 'IL-10', 'categories': [{'measurements': [{'value': '3.6', 'groupId': 'OG000', 'lowerLimit': '3.3', 'upperLimit': '4.3'}, {'value': '3.3', 'groupId': 'OG001', 'lowerLimit': '3.3', 'upperLimit': '3.7'}]}]}, {'title': 'IL-18', 'categories': [{'measurements': [{'value': '219', 'groupId': 'OG000', 'lowerLimit': '165', 'upperLimit': '252'}, {'value': '167', 'groupId': 'OG001', 'lowerLimit': '130', 'upperLimit': '219'}]}]}, {'title': 'IL-2', 'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000', 'lowerLimit': '5.9', 'upperLimit': '5.9'}, {'value': '5.9', 'groupId': 'OG001', 'lowerLimit': '5.9', 'upperLimit': '5.9'}]}]}, {'title': 'IL-3', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '1.6'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '1.6'}]}]}, {'title': 'IL-4', 'categories': [{'measurements': [{'value': '9.4', 'groupId': 'OG000', 'lowerLimit': '9.4', 'upperLimit': '9.4'}, {'value': '9.4', 'groupId': 'OG001', 'lowerLimit': '9.4', 'upperLimit': '9.4'}]}]}, {'title': 'IL-5', 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000', 'lowerLimit': '2.7', 'upperLimit': '2.7'}, {'value': '2.7', 'groupId': 'OG001', 'lowerLimit': '2.7', 'upperLimit': '2.7'}]}]}, {'title': 'IL-6', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '1.6'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '1.6'}]}]}, {'title': 'IL-6r', 'categories': [{'measurements': [{'value': '25000', 'groupId': 'OG000', 'lowerLimit': '18000', 'upperLimit': '33000'}, {'value': '24000', 'groupId': 'OG001', 'lowerLimit': '20000', 'upperLimit': '30000'}]}]}, {'title': 'IL-7', 'categories': [{'measurements': [{'value': '8.2', 'groupId': 'OG000', 'lowerLimit': '8.2', 'upperLimit': '8.2'}, {'value': '8.2', 'groupId': 'OG001', 'lowerLimit': '8.2', 'upperLimit': '8.2'}]}]}, {'title': 'IL-8', 'categories': [{'measurements': [{'value': '4.8', 'groupId': 'OG000', 'lowerLimit': '3.8', 'upperLimit': '6.4'}, {'value': '5', 'groupId': 'OG001', 'lowerLimit': '4.2', 'upperLimit': '5.6'}]}]}, {'title': 'IP-10', 'categories': [{'measurements': [{'value': '455', 'groupId': 'OG000', 'lowerLimit': '291', 'upperLimit': '569'}, {'value': '214', 'groupId': 'OG001', 'lowerLimit': '174', 'upperLimit': '303'}]}]}, {'title': 'MCP-1', 'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000', 'lowerLimit': '55', 'upperLimit': '95'}, {'value': '79', 'groupId': 'OG001', 'lowerLimit': '58', 'upperLimit': '101'}]}]}, {'title': 'MCP-2', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000', 'lowerLimit': '17', 'upperLimit': '25'}, {'value': '20', 'groupId': 'OG001', 'lowerLimit': '15', 'upperLimit': '25'}]}]}, {'title': 'MCP-4', 'categories': [{'measurements': [{'value': '1300', 'groupId': 'OG000', 'lowerLimit': '1010', 'upperLimit': '1600'}, {'value': '1230', 'groupId': 'OG001', 'lowerLimit': '1010', 'upperLimit': '1390'}]}]}, {'title': 'MIG', 'categories': [{'measurements': [{'value': '546', 'groupId': 'OG000', 'lowerLimit': '435', 'upperLimit': '593'}, {'value': '364', 'groupId': 'OG001', 'lowerLimit': '255', 'upperLimit': '620'}]}]}, {'title': 'MIP-1 alpha', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000', 'lowerLimit': '18', 'upperLimit': '22'}, {'value': '18', 'groupId': 'OG001', 'lowerLimit': '18', 'upperLimit': '21'}]}]}, {'title': 'MIP-1 beta', 'categories': [{'measurements': [{'value': '200', 'groupId': 'OG000', 'lowerLimit': '160', 'upperLimit': '265'}, {'value': '149', 'groupId': 'OG001', 'lowerLimit': '126', 'upperLimit': '189'}]}]}, {'title': 'MIP-3 alpha', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000', 'lowerLimit': '14', 'upperLimit': '25'}, {'value': '21', 'groupId': 'OG001', 'lowerLimit': '16', 'upperLimit': '28'}]}]}, {'title': 'MPIF-1', 'categories': [{'measurements': [{'value': '1600', 'groupId': 'OG000', 'lowerLimit': '1300', 'upperLimit': '2000'}, {'value': '1300', 'groupId': 'OG001', 'lowerLimit': '890', 'upperLimit': '1500'}]}]}, {'title': 'TNF-alpha', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000', 'lowerLimit': '13', 'upperLimit': '13'}, {'value': '13', 'groupId': 'OG001', 'lowerLimit': '13', 'upperLimit': '13'}]}]}, {'title': 'TNF-beta', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '3'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Post-dose1 at Day 2', 'description': 'Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).'}, {'type': 'PRIMARY', 'title': 'Cytokines/Chemokines Concentrations in Step 1 of Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HBsAg/AS_1 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}, {'id': 'OG001', 'title': 'Engerix-B_1 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}], 'classes': [{'title': 'E-selectin', 'categories': [{'measurements': [{'value': '6600', 'groupId': 'OG000', 'lowerLimit': '4100', 'upperLimit': '8600'}, {'value': '6700', 'groupId': 'OG001', 'lowerLimit': '4800', 'upperLimit': '8500'}]}]}, {'title': 'GM-CSF', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000', 'lowerLimit': '14', 'upperLimit': '14'}, {'value': '14', 'groupId': 'OG001', 'lowerLimit': '14', 'upperLimit': '14'}]}]}, {'title': 'IFN-γ', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '1.6'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '1.6'}]}]}, {'title': 'IL-10', 'categories': [{'measurements': [{'value': '3.6', 'groupId': 'OG000', 'lowerLimit': '3.3', 'upperLimit': '4.9'}, {'value': '3.3', 'groupId': 'OG001', 'lowerLimit': '3.3', 'upperLimit': '3.9'}]}]}, {'title': 'IL-18', 'categories': [{'measurements': [{'value': '202', 'groupId': 'OG000', 'lowerLimit': '168', 'upperLimit': '265'}, {'value': '191', 'groupId': 'OG001', 'lowerLimit': '126', 'upperLimit': '231'}]}]}, {'title': 'IL-2', 'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000', 'lowerLimit': '5.9', 'upperLimit': '5.9'}, {'value': '5.9', 'groupId': 'OG001', 'lowerLimit': '5.9', 'upperLimit': '5.9'}]}]}, {'title': 'IL-3', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '1.6'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '1.6'}]}]}, {'title': 'IL-4', 'categories': [{'measurements': [{'value': '9.4', 'groupId': 'OG000', 'lowerLimit': '9.4', 'upperLimit': '9.4'}, {'value': '9.4', 'groupId': 'OG001', 'lowerLimit': '9.4', 'upperLimit': '9.4'}]}]}, {'title': 'IL-5', 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000', 'lowerLimit': '2.7', 'upperLimit': '2.7'}, {'value': '2.7', 'groupId': 'OG001', 'lowerLimit': '2.7', 'upperLimit': '2.7'}]}]}, {'title': 'IL-6', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '1.6'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '1.6'}]}]}, {'title': 'IL-6r', 'categories': [{'measurements': [{'value': '27000', 'groupId': 'OG000', 'lowerLimit': '21000', 'upperLimit': '35000'}, {'value': '25000', 'groupId': 'OG001', 'lowerLimit': '21000', 'upperLimit': '31000'}]}]}, {'title': 'IL-7', 'categories': [{'measurements': [{'value': '8.2', 'groupId': 'OG000', 'lowerLimit': '8.2', 'upperLimit': '8.2'}, {'value': '8.2', 'groupId': 'OG001', 'lowerLimit': '8.2', 'upperLimit': '8.2'}]}]}, {'title': 'IL-8', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '4.2', 'upperLimit': '6.9'}, {'value': '5.1', 'groupId': 'OG001', 'lowerLimit': '4.2', 'upperLimit': '6.7'}]}]}, {'title': 'IP-10', 'categories': [{'measurements': [{'value': '235', 'groupId': 'OG000', 'lowerLimit': '178', 'upperLimit': '350'}, {'value': '220.5', 'groupId': 'OG001', 'lowerLimit': '185', 'upperLimit': '279'}]}]}, {'title': 'MCP-1', 'categories': [{'measurements': [{'value': '94', 'groupId': 'OG000', 'lowerLimit': '73', 'upperLimit': '119'}, {'value': '88.5', 'groupId': 'OG001', 'lowerLimit': '71', 'upperLimit': '125'}]}]}, {'title': 'MCP-2', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000', 'lowerLimit': '16', 'upperLimit': '24'}, {'value': '22.5', 'groupId': 'OG001', 'lowerLimit': '18', 'upperLimit': '30'}]}]}, {'title': 'MCP-4', 'categories': [{'measurements': [{'value': '1250', 'groupId': 'OG000', 'lowerLimit': '1040', 'upperLimit': '1390'}, {'value': '1240', 'groupId': 'OG001', 'lowerLimit': '1010', 'upperLimit': '1420'}]}]}, {'title': 'MIG', 'categories': [{'measurements': [{'value': '475', 'groupId': 'OG000', 'lowerLimit': '384', 'upperLimit': '582'}, {'value': '436.5', 'groupId': 'OG001', 'lowerLimit': '304', 'upperLimit': '687'}]}]}, {'title': 'MIP-1 alpha', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000', 'lowerLimit': '18', 'upperLimit': '26'}, {'value': '18', 'groupId': 'OG001', 'lowerLimit': '18', 'upperLimit': '22'}]}]}, {'title': 'MIP-1 beta', 'categories': [{'measurements': [{'value': '171', 'groupId': 'OG000', 'lowerLimit': '142', 'upperLimit': '243'}, {'value': '173.5', 'groupId': 'OG001', 'lowerLimit': '146', 'upperLimit': '213'}]}]}, {'title': 'MIP-3 alpha', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000', 'lowerLimit': '14', 'upperLimit': '26'}, {'value': '22', 'groupId': 'OG001', 'lowerLimit': '16', 'upperLimit': '34'}]}]}, {'title': 'MPIF-1', 'categories': [{'measurements': [{'value': '1600', 'groupId': 'OG000', 'lowerLimit': '1300', 'upperLimit': '2100'}, {'value': '1300', 'groupId': 'OG001', 'lowerLimit': '1100', 'upperLimit': '1500'}]}]}, {'title': 'TNF-alpha', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000', 'lowerLimit': '13', 'upperLimit': '17'}, {'value': '13', 'groupId': 'OG001', 'lowerLimit': '13', 'upperLimit': '13'}]}]}, {'title': 'TNF-beta', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '3'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Post-dose1 at Day 7', 'description': 'Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).'}, {'type': 'PRIMARY', 'title': 'Cytokines/Chemokines Concentrations During Step 1 of Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HBsAg/AS_1 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}, {'id': 'OG001', 'title': 'Engerix-B_1 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}], 'classes': [{'title': 'E-selectin', 'categories': [{'measurements': [{'value': '6200', 'groupId': 'OG000', 'lowerLimit': '4300', 'upperLimit': '9000'}, {'value': '6500', 'groupId': 'OG001', 'lowerLimit': '5200', 'upperLimit': '8000'}]}]}, {'title': 'GM-CSF', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000', 'lowerLimit': '14', 'upperLimit': '14'}, {'value': '14', 'groupId': 'OG001', 'lowerLimit': '14', 'upperLimit': '14'}]}]}, {'title': 'IFN-γ', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '1.6'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '1.6'}]}]}, {'title': 'IL-10', 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000', 'lowerLimit': '3.3', 'upperLimit': '3.4'}, {'value': '3.3', 'groupId': 'OG001', 'lowerLimit': '3.3', 'upperLimit': '3.4'}]}]}, {'title': 'IL-18', 'categories': [{'measurements': [{'value': '202', 'groupId': 'OG000', 'lowerLimit': '151', 'upperLimit': '248'}, {'value': '183', 'groupId': 'OG001', 'lowerLimit': '136', 'upperLimit': '234'}]}]}, {'title': 'IL-2', 'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000', 'lowerLimit': '5.9', 'upperLimit': '5.9'}, {'value': '5.9', 'groupId': 'OG001', 'lowerLimit': '5.9', 'upperLimit': '5.9'}]}]}, {'title': 'IL-3', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '1.6'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '1.6'}]}]}, {'title': 'IL-4', 'categories': [{'measurements': [{'value': '9.4', 'groupId': 'OG000', 'lowerLimit': '9.4', 'upperLimit': '9.4'}, {'value': '9.4', 'groupId': 'OG001', 'lowerLimit': '9.4', 'upperLimit': '9.4'}]}]}, {'title': 'IL-5', 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000', 'lowerLimit': '2.7', 'upperLimit': '2.7'}, {'value': '2.7', 'groupId': 'OG001', 'lowerLimit': '2.7', 'upperLimit': '2.7'}]}]}, {'title': 'IL-6', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '2.3'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '1.6'}]}]}, {'title': 'IL-6r', 'categories': [{'measurements': [{'value': '27000', 'groupId': 'OG000', 'lowerLimit': '20000', 'upperLimit': '32000'}, {'value': '26000', 'groupId': 'OG001', 'lowerLimit': '21000', 'upperLimit': '30000'}]}]}, {'title': 'IL-7', 'categories': [{'measurements': [{'value': '8.2', 'groupId': 'OG000', 'lowerLimit': '8.2', 'upperLimit': '8.2'}, {'value': '8.2', 'groupId': 'OG001', 'lowerLimit': '8.2', 'upperLimit': '8.2'}]}]}, {'title': 'IL-8', 'categories': [{'measurements': [{'value': '4.8', 'groupId': 'OG000', 'lowerLimit': '3.9', 'upperLimit': '6'}, {'value': '4.3', 'groupId': 'OG001', 'lowerLimit': '3.4', 'upperLimit': '5.8'}]}]}, {'title': 'IP-10', 'categories': [{'measurements': [{'value': '245', 'groupId': 'OG000', 'lowerLimit': '211', 'upperLimit': '349'}, {'value': '235', 'groupId': 'OG001', 'lowerLimit': '183', 'upperLimit': '264'}]}]}, {'title': 'MCP-1', 'categories': [{'measurements': [{'value': '99', 'groupId': 'OG000', 'lowerLimit': '72', 'upperLimit': '136'}, {'value': '86', 'groupId': 'OG001', 'lowerLimit': '72', 'upperLimit': '111'}]}]}, {'title': 'MCP-2', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000', 'lowerLimit': '14', 'upperLimit': '23'}, {'value': '20', 'groupId': 'OG001', 'lowerLimit': '14', 'upperLimit': '24'}]}]}, {'title': 'MCP-4', 'categories': [{'measurements': [{'value': '1180', 'groupId': 'OG000', 'lowerLimit': '937', 'upperLimit': '1340'}, {'value': '1010', 'groupId': 'OG001', 'lowerLimit': '937', 'upperLimit': '1210'}]}]}, {'title': 'MIG', 'categories': [{'measurements': [{'value': '475', 'groupId': 'OG000', 'lowerLimit': '393', 'upperLimit': '768'}, {'value': '452', 'groupId': 'OG001', 'lowerLimit': '281', 'upperLimit': '691'}]}]}, {'title': 'MIP-1 alpha', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000', 'lowerLimit': '18', 'upperLimit': '21'}, {'value': '18', 'groupId': 'OG001', 'lowerLimit': '18', 'upperLimit': '18'}]}]}, {'title': 'MIP-1 beta', 'categories': [{'measurements': [{'value': '175', 'groupId': 'OG000', 'lowerLimit': '141', 'upperLimit': '240'}, {'value': '147', 'groupId': 'OG001', 'lowerLimit': '126', 'upperLimit': '181'}]}]}, {'title': 'MIP-3 alpha', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000', 'lowerLimit': '15', 'upperLimit': '30'}, {'value': '20', 'groupId': 'OG001', 'lowerLimit': '16', 'upperLimit': '27'}]}]}, {'title': 'MPIF-1', 'categories': [{'measurements': [{'value': '1500', 'groupId': 'OG000', 'lowerLimit': '1300', 'upperLimit': '1800'}, {'value': '1300', 'groupId': 'OG001', 'lowerLimit': '940', 'upperLimit': '1500'}]}]}, {'title': 'TNF-alpha', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000', 'lowerLimit': '13', 'upperLimit': '13'}, {'value': '13', 'groupId': 'OG001', 'lowerLimit': '13', 'upperLimit': '13'}]}]}, {'title': 'TNF-beta', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '3'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Post-dose1 at Day 30', 'description': 'Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).'}, {'type': 'PRIMARY', 'title': 'Plasma Concentrations of Cytokines and Chemokines - Step 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HBsAg/AS_1 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}, {'id': 'OG001', 'title': 'Engerix-B_1 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}], 'classes': [{'title': 'E-selectin', 'categories': [{'measurements': [{'value': '6300', 'groupId': 'OG000', 'lowerLimit': '3900', 'upperLimit': '7600'}, {'value': '5700', 'groupId': 'OG001', 'lowerLimit': '4900', 'upperLimit': '6800'}]}]}, {'title': 'GM-CSF', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000', 'lowerLimit': '14', 'upperLimit': '14'}, {'value': '14', 'groupId': 'OG001', 'lowerLimit': '14', 'upperLimit': '14'}]}]}, {'title': 'IFN-γ', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '1.6'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '1.6'}]}]}, {'title': 'IL-10', 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000', 'lowerLimit': '3.3', 'upperLimit': '4.5'}, {'value': '3.3', 'groupId': 'OG001', 'lowerLimit': '3.3', 'upperLimit': '4.3'}]}]}, {'title': 'IL-18', 'categories': [{'measurements': [{'value': '171', 'groupId': 'OG000', 'lowerLimit': '143', 'upperLimit': '223'}, {'value': '176', 'groupId': 'OG001', 'lowerLimit': '127', 'upperLimit': '207'}]}]}, {'title': 'IL-2', 'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000', 'lowerLimit': '5.9', 'upperLimit': '5.9'}, {'value': '5.9', 'groupId': 'OG001', 'lowerLimit': '5.9', 'upperLimit': '5.9'}]}]}, {'title': 'IL-3', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '1.6'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '1.6'}]}]}, {'title': 'IL-4', 'categories': [{'measurements': [{'value': '9.4', 'groupId': 'OG000', 'lowerLimit': '9.4', 'upperLimit': '9.4'}, {'value': '9.4', 'groupId': 'OG001', 'lowerLimit': '9.4', 'upperLimit': '9.4'}]}]}, {'title': 'IL-5', 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000', 'lowerLimit': '2.7', 'upperLimit': '2.7'}, {'value': '2.7', 'groupId': 'OG001', 'lowerLimit': '2.7', 'upperLimit': '2.7'}]}]}, {'title': 'IL-6', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '1.6'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '1.6'}]}]}, {'title': 'IL-6r', 'categories': [{'measurements': [{'value': '24000', 'groupId': 'OG000', 'lowerLimit': '18000', 'upperLimit': '30000'}, {'value': '25000', 'groupId': 'OG001', 'lowerLimit': '20000', 'upperLimit': '31000'}]}]}, {'title': 'IL-7', 'categories': [{'measurements': [{'value': '8.2', 'groupId': 'OG000', 'lowerLimit': '8.2', 'upperLimit': '8.2'}, {'value': '8.2', 'groupId': 'OG001', 'lowerLimit': '8.2', 'upperLimit': '8.2'}]}]}, {'title': 'IL-8', 'categories': [{'measurements': [{'value': '3.2', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '5.6'}, {'value': '4.3', 'groupId': 'OG001', 'lowerLimit': '2.7', 'upperLimit': '5'}]}]}, {'title': 'IP-10', 'categories': [{'measurements': [{'value': '223', 'groupId': 'OG000', 'lowerLimit': '189', 'upperLimit': '336'}, {'value': '215', 'groupId': 'OG001', 'lowerLimit': '173', 'upperLimit': '247'}]}]}, {'title': 'MCP-1', 'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000', 'lowerLimit': '58', 'upperLimit': '112'}, {'value': '87', 'groupId': 'OG001', 'lowerLimit': '66', 'upperLimit': '104'}]}]}, {'title': 'MCP-2', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000', 'lowerLimit': '12', 'upperLimit': '23'}, {'value': '18', 'groupId': 'OG001', 'lowerLimit': '15', 'upperLimit': '22'}]}]}, {'title': 'MCP-4', 'categories': [{'measurements': [{'value': '1250', 'groupId': 'OG000', 'lowerLimit': '1030', 'upperLimit': '1400'}, {'value': '1090', 'groupId': 'OG001', 'lowerLimit': '1020', 'upperLimit': '1330'}]}]}, {'title': 'MIG', 'categories': [{'measurements': [{'value': '421', 'groupId': 'OG000', 'lowerLimit': '361', 'upperLimit': '856'}, {'value': '367', 'groupId': 'OG001', 'lowerLimit': '269', 'upperLimit': '575'}]}]}, {'title': 'MIP-1 alpha', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000', 'lowerLimit': '18', 'upperLimit': '22'}, {'value': '18', 'groupId': 'OG001', 'lowerLimit': '18', 'upperLimit': '20'}]}]}, {'title': 'MIP-1 beta', 'categories': [{'measurements': [{'value': '164', 'groupId': 'OG000', 'lowerLimit': '132', 'upperLimit': '196'}, {'value': '136', 'groupId': 'OG001', 'lowerLimit': '115', 'upperLimit': '170'}]}]}, {'title': 'MIP-3 alpha', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000', 'lowerLimit': '10', 'upperLimit': '22'}, {'value': '14', 'groupId': 'OG001', 'lowerLimit': '11', 'upperLimit': '19'}]}]}, {'title': 'MPIF-1', 'categories': [{'measurements': [{'value': '1400', 'groupId': 'OG000', 'lowerLimit': '1200', 'upperLimit': '1500'}, {'value': '1200', 'groupId': 'OG001', 'lowerLimit': '930', 'upperLimit': '1500'}]}]}, {'title': 'TNF-alpha', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000', 'lowerLimit': '13', 'upperLimit': '13'}, {'value': '13', 'groupId': 'OG001', 'lowerLimit': '13', 'upperLimit': '13'}]}]}, {'title': 'TNF-beta', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '3'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Post-dose 2 at Day 30 plus 1.5 Hours', 'description': 'Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).'}, {'type': 'PRIMARY', 'title': 'Plasma Concentrations of Cytokines and Chemokines - Study Step 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HBsAg/AS_1 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}, {'id': 'OG001', 'title': 'Engerix-B_1 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}], 'classes': [{'title': 'E-selectin', 'categories': [{'measurements': [{'value': '6550', 'groupId': 'OG000', 'lowerLimit': '4000', 'upperLimit': '8200'}, {'value': '5700', 'groupId': 'OG001', 'lowerLimit': '4450', 'upperLimit': '6850'}]}]}, {'title': 'GM-CSF', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000', 'lowerLimit': '14', 'upperLimit': '14'}, {'value': '14', 'groupId': 'OG001', 'lowerLimit': '14', 'upperLimit': '14'}]}]}, {'title': 'IFN-γ', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '1.6'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '1.6'}]}]}, {'title': 'IL-10', 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000', 'lowerLimit': '3.3', 'upperLimit': '4.5'}, {'value': '3.3', 'groupId': 'OG001', 'lowerLimit': '3.3', 'upperLimit': '3.4'}]}]}, {'title': 'IL-18', 'categories': [{'measurements': [{'value': '171.5', 'groupId': 'OG000', 'lowerLimit': '146', 'upperLimit': '204'}, {'value': '158', 'groupId': 'OG001', 'lowerLimit': '104', 'upperLimit': '206.5'}]}]}, {'title': 'IL-2', 'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000', 'lowerLimit': '5.9', 'upperLimit': '5.9'}, {'value': '5.9', 'groupId': 'OG001', 'lowerLimit': '5.9', 'upperLimit': '5.9'}]}]}, {'title': 'IL-3', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '1.6'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '1.6'}]}]}, {'title': 'IL-4', 'categories': [{'measurements': [{'value': '9.4', 'groupId': 'OG000', 'lowerLimit': '9.4', 'upperLimit': '9.4'}, {'value': '9.4', 'groupId': 'OG001', 'lowerLimit': '9.4', 'upperLimit': '9.4'}]}]}, {'title': 'IL-5', 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000', 'lowerLimit': '2.7', 'upperLimit': '2.7'}, {'value': '2.7', 'groupId': 'OG001', 'lowerLimit': '2.7', 'upperLimit': '2.7'}]}]}, {'title': 'IL-6', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '2.5'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '1.6'}]}]}, {'title': 'IL-6r', 'categories': [{'measurements': [{'value': '26000', 'groupId': 'OG000', 'lowerLimit': '18000', 'upperLimit': '31000'}, {'value': '23000', 'groupId': 'OG001', 'lowerLimit': '19000', 'upperLimit': '28500'}]}]}, {'title': 'IL-7', 'categories': [{'measurements': [{'value': '8.2', 'groupId': 'OG000', 'lowerLimit': '8.2', 'upperLimit': '8.2'}, {'value': '8.2', 'groupId': 'OG001', 'lowerLimit': '8.2', 'upperLimit': '8.2'}]}]}, {'title': 'IL-8', 'categories': [{'measurements': [{'value': '4.7', 'groupId': 'OG000', 'lowerLimit': '3.9', 'upperLimit': '6'}, {'value': '4.5', 'groupId': 'OG001', 'lowerLimit': '3.8', 'upperLimit': '5'}]}]}, {'title': 'IP-10', 'categories': [{'measurements': [{'value': '208', 'groupId': 'OG000', 'lowerLimit': '182', 'upperLimit': '275'}, {'value': '205.5', 'groupId': 'OG001', 'lowerLimit': '176', 'upperLimit': '243.5'}]}]}, {'title': 'MCP-1', 'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000', 'lowerLimit': '62', 'upperLimit': '95'}, {'value': '75', 'groupId': 'OG001', 'lowerLimit': '51', 'upperLimit': '85'}]}]}, {'title': 'MCP-2', 'categories': [{'measurements': [{'value': '15.5', 'groupId': 'OG000', 'lowerLimit': '12', 'upperLimit': '27'}, {'value': '18', 'groupId': 'OG001', 'lowerLimit': '14.5', 'upperLimit': '22.5'}]}]}, {'title': 'MCP-4', 'categories': [{'measurements': [{'value': '1095', 'groupId': 'OG000', 'lowerLimit': '979', 'upperLimit': '1410'}, {'value': '1085', 'groupId': 'OG001', 'lowerLimit': '824.5', 'upperLimit': '1250'}]}]}, {'title': 'MIG', 'categories': [{'measurements': [{'value': '378.5', 'groupId': 'OG000', 'lowerLimit': '313', 'upperLimit': '513'}, {'value': '358', 'groupId': 'OG001', 'lowerLimit': '237', 'upperLimit': '650.5'}]}]}, {'title': 'MIP-1 alpha', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000', 'lowerLimit': '18', 'upperLimit': '20'}, {'value': '18', 'groupId': 'OG001', 'lowerLimit': '18', 'upperLimit': '18.5'}]}]}, {'title': 'MIP-1 beta', 'categories': [{'measurements': [{'value': '153', 'groupId': 'OG000', 'lowerLimit': '135', 'upperLimit': '220'}, {'value': '138', 'groupId': 'OG001', 'lowerLimit': '123.5', 'upperLimit': '157.5'}]}]}, {'title': 'MIP-3 alpha', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000', 'lowerLimit': '10', 'upperLimit': '22'}, {'value': '14', 'groupId': 'OG001', 'lowerLimit': '10', 'upperLimit': '15.5'}]}]}, {'title': 'MPIF-1', 'categories': [{'measurements': [{'value': '1500', 'groupId': 'OG000', 'lowerLimit': '1200', 'upperLimit': '1600'}, {'value': '1200', 'groupId': 'OG001', 'lowerLimit': '980', 'upperLimit': '1450'}]}]}, {'title': 'TNF-alpha', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000', 'lowerLimit': '13', 'upperLimit': '13'}, {'value': '13', 'groupId': 'OG001', 'lowerLimit': '13', 'upperLimit': '13'}]}]}, {'title': 'TNF-beta', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '3'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Post-dose 2 at Day 30 plus 3 Hours', 'description': 'Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).'}, {'type': 'PRIMARY', 'title': 'Plasma Concentrations of Cytokines and Chemokines in Step 1 of Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HBsAg/AS_1 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}, {'id': 'OG001', 'title': 'Engerix-B_1 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}], 'classes': [{'title': 'E-selectin', 'categories': [{'measurements': [{'value': '6000', 'groupId': 'OG000', 'lowerLimit': '4200', 'upperLimit': '8100'}, {'value': '5850', 'groupId': 'OG001', 'lowerLimit': '4550', 'upperLimit': '7000'}]}]}, {'title': 'GM-CSF', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000', 'lowerLimit': '14', 'upperLimit': '14'}, {'value': '14', 'groupId': 'OG001', 'lowerLimit': '14', 'upperLimit': '14'}]}]}, {'title': 'IFN-γ', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '1.6'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '1.6'}]}]}, {'title': 'IL-10', 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000', 'lowerLimit': '3.3', 'upperLimit': '3.7'}, {'value': '3.3', 'groupId': 'OG001', 'lowerLimit': '3.3', 'upperLimit': '3.3'}]}]}, {'title': 'IL-18', 'categories': [{'measurements': [{'value': '173.5', 'groupId': 'OG000', 'lowerLimit': '151', 'upperLimit': '227'}, {'value': '183', 'groupId': 'OG001', 'lowerLimit': '127.5', 'upperLimit': '211.5'}]}]}, {'title': 'IL-2', 'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000', 'lowerLimit': '5.9', 'upperLimit': '5.9'}, {'value': '5.9', 'groupId': 'OG001', 'lowerLimit': '5.9', 'upperLimit': '5.9'}]}]}, {'title': 'IL-3', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '1.6'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '1.6'}]}]}, {'title': 'IL-4', 'categories': [{'measurements': [{'value': '9.4', 'groupId': 'OG000', 'lowerLimit': '9.4', 'upperLimit': '9.4'}, {'value': '9.4', 'groupId': 'OG001', 'lowerLimit': '9.4', 'upperLimit': '9.4'}]}]}, {'title': 'IL-5', 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000', 'lowerLimit': '2.7', 'upperLimit': '2.7'}, {'value': '2.7', 'groupId': 'OG001', 'lowerLimit': '2.7', 'upperLimit': '2.7'}]}]}, {'title': 'IL-6', 'categories': [{'measurements': [{'value': '4.4', 'groupId': 'OG000', 'lowerLimit': '2.8', 'upperLimit': '6.7'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '1.6'}]}]}, {'title': 'IL-6r', 'categories': [{'measurements': [{'value': '23000', 'groupId': 'OG000', 'lowerLimit': '18000', 'upperLimit': '29000'}, {'value': '24500', 'groupId': 'OG001', 'lowerLimit': '20500', 'upperLimit': '30500'}]}]}, {'title': 'IL-7', 'categories': [{'measurements': [{'value': '8.2', 'groupId': 'OG000', 'lowerLimit': '8.2', 'upperLimit': '8.2'}, {'value': '8.2', 'groupId': 'OG001', 'lowerLimit': '8.2', 'upperLimit': '8.2'}]}]}, {'title': 'IL-8', 'categories': [{'measurements': [{'value': '5.2', 'groupId': 'OG000', 'lowerLimit': '3.5', 'upperLimit': '6.7'}, {'value': '4.5', 'groupId': 'OG001', 'lowerLimit': '3.5', 'upperLimit': '5.2'}]}]}, {'title': 'IP-10', 'categories': [{'measurements': [{'value': '210.5', 'groupId': 'OG000', 'lowerLimit': '182', 'upperLimit': '248'}, {'value': '196.5', 'groupId': 'OG001', 'lowerLimit': '160', 'upperLimit': '248.5'}]}]}, {'title': 'MCP-1', 'categories': [{'measurements': [{'value': '116.5', 'groupId': 'OG000', 'lowerLimit': '98', 'upperLimit': '132'}, {'value': '95', 'groupId': 'OG001', 'lowerLimit': '79', 'upperLimit': '121'}]}]}, {'title': 'MCP-2', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000', 'lowerLimit': '12', 'upperLimit': '24'}, {'value': '18.5', 'groupId': 'OG001', 'lowerLimit': '15', 'upperLimit': '24'}]}]}, {'title': 'MCP-4', 'categories': [{'measurements': [{'value': '1245', 'groupId': 'OG000', 'lowerLimit': '954', 'upperLimit': '1590'}, {'value': '1065', 'groupId': 'OG001', 'lowerLimit': '936', 'upperLimit': '1350'}]}]}, {'title': 'MIG', 'categories': [{'measurements': [{'value': '375', 'groupId': 'OG000', 'lowerLimit': '320', 'upperLimit': '505'}, {'value': '387.5', 'groupId': 'OG001', 'lowerLimit': '239', 'upperLimit': '671'}]}]}, {'title': 'MIP-1 alpha', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000', 'lowerLimit': '18', 'upperLimit': '19'}, {'value': '18', 'groupId': 'OG001', 'lowerLimit': '18', 'upperLimit': '18'}]}]}, {'title': 'MIP-1 beta', 'categories': [{'measurements': [{'value': '177.5', 'groupId': 'OG000', 'lowerLimit': '128', 'upperLimit': '225'}, {'value': '139.5', 'groupId': 'OG001', 'lowerLimit': '127.5', 'upperLimit': '163.5'}]}]}, {'title': 'MIP-3 alpha', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000', 'lowerLimit': '10', 'upperLimit': '24'}, {'value': '16', 'groupId': 'OG001', 'lowerLimit': '12', 'upperLimit': '22'}]}]}, {'title': 'MPIF-1', 'categories': [{'measurements': [{'value': '1400', 'groupId': 'OG000', 'lowerLimit': '1200', 'upperLimit': '1600'}, {'value': '1300', 'groupId': 'OG001', 'lowerLimit': '1015', 'upperLimit': '1700'}]}]}, {'title': 'TNF-alpha', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000', 'lowerLimit': '13', 'upperLimit': '13'}, {'value': '13', 'groupId': 'OG001', 'lowerLimit': '13', 'upperLimit': '13'}]}]}, {'title': 'TNF-beta', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '3'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Post-dose 2 at Day 30 plus 6 hours', 'description': 'Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).'}, {'type': 'PRIMARY', 'title': 'Plasma Concentrations of Cytokines and Chemokines During Step 1 of Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HBsAg/AS_1 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}, {'id': 'OG001', 'title': 'Engerix-B_1 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}], 'classes': [{'title': 'E-selectin', 'categories': [{'measurements': [{'value': '6200', 'groupId': 'OG000', 'lowerLimit': '4100', 'upperLimit': '7400'}, {'value': '5500', 'groupId': 'OG001', 'lowerLimit': '4350', 'upperLimit': '6850'}]}]}, {'title': 'GM-CSF', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000', 'lowerLimit': '14', 'upperLimit': '14'}, {'value': '14', 'groupId': 'OG001', 'lowerLimit': '14', 'upperLimit': '14'}]}]}, {'title': 'IFN-γ', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '1.6'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '1.6'}]}]}, {'title': 'IL-10', 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000', 'lowerLimit': '3.3', 'upperLimit': '5.2'}, {'value': '3.3', 'groupId': 'OG001', 'lowerLimit': '3.3', 'upperLimit': '3.4'}]}]}, {'title': 'IL-18', 'categories': [{'measurements': [{'value': '177', 'groupId': 'OG000', 'lowerLimit': '139', 'upperLimit': '240'}, {'value': '165', 'groupId': 'OG001', 'lowerLimit': '115', 'upperLimit': '229.5'}]}]}, {'title': 'IL-2', 'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000', 'lowerLimit': '5.9', 'upperLimit': '5.9'}, {'value': '5.9', 'groupId': 'OG001', 'lowerLimit': '5.9', 'upperLimit': '6.6'}]}]}, {'title': 'IL-3', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '1.6'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '1.6'}]}]}, {'title': 'IL-4', 'categories': [{'measurements': [{'value': '9.4', 'groupId': 'OG000', 'lowerLimit': '9.4', 'upperLimit': '9.4'}, {'value': '9.4', 'groupId': 'OG001', 'lowerLimit': '9.4', 'upperLimit': '9.4'}]}]}, {'title': 'IL-5', 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000', 'lowerLimit': '2.7', 'upperLimit': '2.7'}, {'value': '2.7', 'groupId': 'OG001', 'lowerLimit': '2.7', 'upperLimit': '2.7'}]}]}, {'title': 'IL-6', 'categories': [{'measurements': [{'value': '4.8', 'groupId': 'OG000', 'lowerLimit': '3.2', 'upperLimit': '6.7'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '1.6'}]}]}, {'title': 'IL-6r', 'categories': [{'measurements': [{'value': '23000', 'groupId': 'OG000', 'lowerLimit': '17000', 'upperLimit': '30000'}, {'value': '24500', 'groupId': 'OG001', 'lowerLimit': '18500', 'upperLimit': '30500'}]}]}, {'title': 'IL-7', 'categories': [{'measurements': [{'value': '8.2', 'groupId': 'OG000', 'lowerLimit': '8.2', 'upperLimit': '8.2'}, {'value': '8.2', 'groupId': 'OG001', 'lowerLimit': '8.2', 'upperLimit': '8.2'}]}]}, {'title': 'IL-8', 'categories': [{'measurements': [{'value': '4.1', 'groupId': 'OG000', 'lowerLimit': '3.2', 'upperLimit': '5.5'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '3.2', 'upperLimit': '5.4'}]}]}, {'title': 'IP-10', 'categories': [{'measurements': [{'value': '217', 'groupId': 'OG000', 'lowerLimit': '180', 'upperLimit': '326'}, {'value': '204', 'groupId': 'OG001', 'lowerLimit': '168', 'upperLimit': '234'}]}]}, {'title': 'MCP-1', 'categories': [{'measurements': [{'value': '103', 'groupId': 'OG000', 'lowerLimit': '88', 'upperLimit': '119'}, {'value': '80', 'groupId': 'OG001', 'lowerLimit': '55', 'upperLimit': '106'}]}]}, {'title': 'MCP-2', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000', 'lowerLimit': '14', 'upperLimit': '24'}, {'value': '18.5', 'groupId': 'OG001', 'lowerLimit': '14.5', 'upperLimit': '20.5'}]}]}, {'title': 'MCP-4', 'categories': [{'measurements': [{'value': '1190', 'groupId': 'OG000', 'lowerLimit': '999', 'upperLimit': '1470'}, {'value': '1075', 'groupId': 'OG001', 'lowerLimit': '820', 'upperLimit': '1295'}]}]}, {'title': 'MIG', 'categories': [{'measurements': [{'value': '424', 'groupId': 'OG000', 'lowerLimit': '384', 'upperLimit': '621'}, {'value': '350', 'groupId': 'OG001', 'lowerLimit': '300', 'upperLimit': '620'}]}]}, {'title': 'MIP-1 alpha', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000', 'lowerLimit': '18', 'upperLimit': '19'}, {'value': '18', 'groupId': 'OG001', 'lowerLimit': '18', 'upperLimit': '18'}]}]}, {'title': 'MIP-1 beta', 'categories': [{'measurements': [{'value': '167', 'groupId': 'OG000', 'lowerLimit': '120', 'upperLimit': '220'}, {'value': '123.5', 'groupId': 'OG001', 'lowerLimit': '108.5', 'upperLimit': '146.5'}]}]}, {'title': 'MIP-3 alpha', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000', 'lowerLimit': '14', 'upperLimit': '23'}, {'value': '15.5', 'groupId': 'OG001', 'lowerLimit': '11', 'upperLimit': '19'}]}]}, {'title': 'MPIF-1', 'categories': [{'measurements': [{'value': '1400', 'groupId': 'OG000', 'lowerLimit': '1100', 'upperLimit': '1600'}, {'value': '1200', 'groupId': 'OG001', 'lowerLimit': '950', 'upperLimit': '1400'}]}]}, {'title': 'TNF-alpha', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000', 'lowerLimit': '13', 'upperLimit': '13'}, {'value': '13', 'groupId': 'OG001', 'lowerLimit': '13', 'upperLimit': '13'}]}]}, {'title': 'TNF-beta', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '3'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Post-dose 2 at Day 30 plus 9 Hours', 'description': 'Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).'}, {'type': 'PRIMARY', 'title': 'Plasma Concentrations of Cytokines/Chemokines During Step 1 of Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HBsAg/AS_1 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}, {'id': 'OG001', 'title': 'Engerix-B_1 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}], 'classes': [{'title': 'E-selectin', 'categories': [{'measurements': [{'value': '5800', 'groupId': 'OG000', 'lowerLimit': '4000', 'upperLimit': '7800'}, {'value': '5800', 'groupId': 'OG001', 'lowerLimit': '4500', 'upperLimit': '7000'}]}]}, {'title': 'GM-CSF', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000', 'lowerLimit': '14', 'upperLimit': '14'}, {'value': '14', 'groupId': 'OG001', 'lowerLimit': '14', 'upperLimit': '14'}]}]}, {'title': 'IFN-γ', 'categories': [{'measurements': [{'value': '2.3', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '3.1'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '1.6'}]}]}, {'title': 'IL-10', 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000', 'lowerLimit': '3.3', 'upperLimit': '3.8'}, {'value': '3.3', 'groupId': 'OG001', 'lowerLimit': '3.3', 'upperLimit': '3.3'}]}]}, {'title': 'IL-18', 'categories': [{'measurements': [{'value': '166', 'groupId': 'OG000', 'lowerLimit': '146', 'upperLimit': '212'}, {'value': '174', 'groupId': 'OG001', 'lowerLimit': '124', 'upperLimit': '220'}]}]}, {'title': 'IL-2', 'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000', 'lowerLimit': '5.9', 'upperLimit': '5.9'}, {'value': '5.9', 'groupId': 'OG001', 'lowerLimit': '5.9', 'upperLimit': '5.9'}]}]}, {'title': 'IL-3', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '1.6'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '1.6'}]}]}, {'title': 'IL-4', 'categories': [{'measurements': [{'value': '9.4', 'groupId': 'OG000', 'lowerLimit': '9.4', 'upperLimit': '9.4'}, {'value': '9.4', 'groupId': 'OG001', 'lowerLimit': '9.4', 'upperLimit': '9.4'}]}]}, {'title': 'IL-5', 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000', 'lowerLimit': '2.7', 'upperLimit': '2.7'}, {'value': '2.7', 'groupId': 'OG001', 'lowerLimit': '2.7', 'upperLimit': '2.7'}]}]}, {'title': 'IL-6', 'categories': [{'measurements': [{'value': '6.4', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '9'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '1.7'}]}]}, {'title': 'IL-6r', 'categories': [{'measurements': [{'value': '23000', 'groupId': 'OG000', 'lowerLimit': '21000', 'upperLimit': '31000'}, {'value': '24000', 'groupId': 'OG001', 'lowerLimit': '21000', 'upperLimit': '32000'}]}]}, {'title': 'IL-7', 'categories': [{'measurements': [{'value': '8.2', 'groupId': 'OG000', 'lowerLimit': '8.2', 'upperLimit': '8.2'}, {'value': '8.2', 'groupId': 'OG001', 'lowerLimit': '8.2', 'upperLimit': '8.2'}]}]}, {'title': 'IL-8', 'categories': [{'measurements': [{'value': '4.9', 'groupId': 'OG000', 'lowerLimit': '4.1', 'upperLimit': '6'}, {'value': '5.2', 'groupId': 'OG001', 'lowerLimit': '3.2', 'upperLimit': '6'}]}]}, {'title': 'IP-10', 'categories': [{'measurements': [{'value': '240', 'groupId': 'OG000', 'lowerLimit': '228', 'upperLimit': '335'}, {'value': '200', 'groupId': 'OG001', 'lowerLimit': '166', 'upperLimit': '240'}]}]}, {'title': 'MCP-1', 'categories': [{'measurements': [{'value': '117', 'groupId': 'OG000', 'lowerLimit': '96', 'upperLimit': '150'}, {'value': '95', 'groupId': 'OG001', 'lowerLimit': '71', 'upperLimit': '121'}]}]}, {'title': 'MCP-2', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000', 'lowerLimit': '14', 'upperLimit': '26'}, {'value': '18', 'groupId': 'OG001', 'lowerLimit': '15', 'upperLimit': '22'}]}]}, {'title': 'MCP-4', 'categories': [{'measurements': [{'value': '1100', 'groupId': 'OG000', 'lowerLimit': '916', 'upperLimit': '1330'}, {'value': '1040', 'groupId': 'OG001', 'lowerLimit': '852', 'upperLimit': '1170'}]}]}, {'title': 'MIG', 'categories': [{'measurements': [{'value': '499', 'groupId': 'OG000', 'lowerLimit': '398', 'upperLimit': '872'}, {'value': '377', 'groupId': 'OG001', 'lowerLimit': '290', 'upperLimit': '689'}]}]}, {'title': 'MIP-1 alpha', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000', 'lowerLimit': '18', 'upperLimit': '20'}, {'value': '18', 'groupId': 'OG001', 'lowerLimit': '18', 'upperLimit': '18'}]}]}, {'title': 'MIP-1 beta', 'categories': [{'measurements': [{'value': '191', 'groupId': 'OG000', 'lowerLimit': '162', 'upperLimit': '238'}, {'value': '134', 'groupId': 'OG001', 'lowerLimit': '118', 'upperLimit': '162'}]}]}, {'title': 'MIP-3 alpha', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000', 'lowerLimit': '15', 'upperLimit': '26'}, {'value': '14', 'groupId': 'OG001', 'lowerLimit': '11', 'upperLimit': '20'}]}]}, {'title': 'MPIF-1', 'categories': [{'measurements': [{'value': '1500', 'groupId': 'OG000', 'lowerLimit': '1100', 'upperLimit': '1700'}, {'value': '1300', 'groupId': 'OG001', 'lowerLimit': '1100', 'upperLimit': '1500'}]}]}, {'title': 'TNF-alpha', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000', 'lowerLimit': '13', 'upperLimit': '13'}, {'value': '13', 'groupId': 'OG001', 'lowerLimit': '13', 'upperLimit': '13'}]}]}, {'title': 'TNF-beta', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '3'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Post-dose 2 at Day 30 plus 12 Hours', 'description': 'Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).'}, {'type': 'PRIMARY', 'title': 'Plasma Concentrations of Cytokines/Chemokines - Step 1 of Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HBsAg/AS_1 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}, {'id': 'OG001', 'title': 'Engerix-B_1 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}], 'classes': [{'title': 'E-selectin', 'categories': [{'measurements': [{'value': '5400', 'groupId': 'OG000', 'lowerLimit': '3400', 'upperLimit': '8000'}, {'value': '4500', 'groupId': 'OG001', 'lowerLimit': '2900', 'upperLimit': '5800'}]}]}, {'title': 'GM-CSF', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000', 'lowerLimit': '14', 'upperLimit': '14'}, {'value': '14', 'groupId': 'OG001', 'lowerLimit': '14', 'upperLimit': '14'}]}]}, {'title': 'IFN-γ', 'categories': [{'measurements': [{'value': '5.2', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '7.4'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '1.6'}]}]}, {'title': 'IL-10', 'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000', 'lowerLimit': '3.3', 'upperLimit': '6'}, {'value': '3.3', 'groupId': 'OG001', 'lowerLimit': '3.3', 'upperLimit': '3.4'}]}]}, {'title': 'IL-18', 'categories': [{'measurements': [{'value': '164.5', 'groupId': 'OG000', 'lowerLimit': '151', 'upperLimit': '241'}, {'value': '168', 'groupId': 'OG001', 'lowerLimit': '128', 'upperLimit': '197'}]}]}, {'title': 'IL-2', 'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000', 'lowerLimit': '5.9', 'upperLimit': '5.9'}, {'value': '5.9', 'groupId': 'OG001', 'lowerLimit': '5.9', 'upperLimit': '5.9'}]}]}, {'title': 'IL-3', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '1.6'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '1.6'}]}]}, {'title': 'IL-4', 'categories': [{'measurements': [{'value': '9.4', 'groupId': 'OG000', 'lowerLimit': '9.4', 'upperLimit': '9.4'}, {'value': '9.4', 'groupId': 'OG001', 'lowerLimit': '9.4', 'upperLimit': '9.4'}]}]}, {'title': 'IL-5', 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000', 'lowerLimit': '2.7', 'upperLimit': '2.7'}, {'value': '2.7', 'groupId': 'OG001', 'lowerLimit': '2.7', 'upperLimit': '2.7'}]}]}, {'title': 'IL-6', 'categories': [{'measurements': [{'value': '6.3', 'groupId': 'OG000', 'lowerLimit': '4.2', 'upperLimit': '8.3'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '1.6'}]}]}, {'title': 'IL-6r', 'categories': [{'measurements': [{'value': '19500', 'groupId': 'OG000', 'lowerLimit': '13000', 'upperLimit': '24000'}, {'value': '24000', 'groupId': 'OG001', 'lowerLimit': '17000', 'upperLimit': '32000'}]}]}, {'title': 'IL-7', 'categories': [{'measurements': [{'value': '8.2', 'groupId': 'OG000', 'lowerLimit': '8.2', 'upperLimit': '8.2'}, {'value': '8.2', 'groupId': 'OG001', 'lowerLimit': '8.2', 'upperLimit': '8.2'}]}]}, {'title': 'IL-8', 'categories': [{'measurements': [{'value': '4.8', 'groupId': 'OG000', 'lowerLimit': '4.1', 'upperLimit': '5.4'}, {'value': '5', 'groupId': 'OG001', 'lowerLimit': '3.5', 'upperLimit': '5.9'}]}]}, {'title': 'IP-10', 'categories': [{'measurements': [{'value': '589.5', 'groupId': 'OG000', 'lowerLimit': '296', 'upperLimit': '715'}, {'value': '216', 'groupId': 'OG001', 'lowerLimit': '196', 'upperLimit': '430'}]}]}, {'title': 'MCP-1', 'categories': [{'measurements': [{'value': '104.5', 'groupId': 'OG000', 'lowerLimit': '76', 'upperLimit': '116'}, {'value': '96', 'groupId': 'OG001', 'lowerLimit': '91', 'upperLimit': '106'}]}]}, {'title': 'MCP-2', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000', 'lowerLimit': '19', 'upperLimit': '54'}, {'value': '22', 'groupId': 'OG001', 'lowerLimit': '16', 'upperLimit': '23'}]}]}, {'title': 'MCP-4', 'categories': [{'measurements': [{'value': '1220', 'groupId': 'OG000', 'lowerLimit': '1090', 'upperLimit': '1290'}, {'value': '1260', 'groupId': 'OG001', 'lowerLimit': '1000', 'upperLimit': '1340'}]}]}, {'title': 'MIG', 'categories': [{'measurements': [{'value': '565.5', 'groupId': 'OG000', 'lowerLimit': '373', 'upperLimit': '791'}, {'value': '442', 'groupId': 'OG001', 'lowerLimit': '300', 'upperLimit': '633'}]}]}, {'title': 'MIP-1 alpha', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000', 'lowerLimit': '18', 'upperLimit': '23'}, {'value': '18', 'groupId': 'OG001', 'lowerLimit': '18', 'upperLimit': '23'}]}]}, {'title': 'MIP-1 beta', 'categories': [{'measurements': [{'value': '283.5', 'groupId': 'OG000', 'lowerLimit': '228', 'upperLimit': '327'}, {'value': '144', 'groupId': 'OG001', 'lowerLimit': '111', 'upperLimit': '176'}]}]}, {'title': 'MIP-3 alpha', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000', 'lowerLimit': '19', 'upperLimit': '31'}, {'value': '17', 'groupId': 'OG001', 'lowerLimit': '11', 'upperLimit': '20'}]}]}, {'title': 'MPIF-1', 'categories': [{'measurements': [{'value': '1600', 'groupId': 'OG000', 'lowerLimit': '1300', 'upperLimit': '2300'}, {'value': '1400', 'groupId': 'OG001', 'lowerLimit': '1100', 'upperLimit': '1700'}]}]}, {'title': 'TNF-alpha', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000', 'lowerLimit': '13', 'upperLimit': '13'}, {'value': '13', 'groupId': 'OG001', 'lowerLimit': '13', 'upperLimit': '13'}]}]}, {'title': 'TNF-beta', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '3'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Post-dose 2 at Day 30 plus 18 Hours', 'description': 'Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).'}, {'type': 'PRIMARY', 'title': 'Plasma Concentrations of Cytokines/Chemokines in Step 1 of Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HBsAg/AS_1 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}, {'id': 'OG001', 'title': 'Engerix-B_1 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}], 'classes': [{'title': 'E-selectin', 'categories': [{'measurements': [{'value': '6800', 'groupId': 'OG000', 'lowerLimit': '4300', 'upperLimit': '8200'}, {'value': '5800', 'groupId': 'OG001', 'lowerLimit': '5200', 'upperLimit': '7100'}]}]}, {'title': 'GM-CSF', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000', 'lowerLimit': '14', 'upperLimit': '14'}, {'value': '14', 'groupId': 'OG001', 'lowerLimit': '14', 'upperLimit': '14'}]}]}, {'title': 'IFN-γ', 'categories': [{'measurements': [{'value': '4.8', 'groupId': 'OG000', 'lowerLimit': '1.7', 'upperLimit': '8.6'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '1.6'}]}]}, {'title': 'IL-10', 'categories': [{'measurements': [{'value': '4.8', 'groupId': 'OG000', 'lowerLimit': '3.3', 'upperLimit': '6.3'}, {'value': '3.3', 'groupId': 'OG001', 'lowerLimit': '3.3', 'upperLimit': '3.3'}]}]}, {'title': 'IL-18', 'categories': [{'measurements': [{'value': '185', 'groupId': 'OG000', 'lowerLimit': '151', 'upperLimit': '258'}, {'value': '166', 'groupId': 'OG001', 'lowerLimit': '137', 'upperLimit': '217'}]}]}, {'title': 'IL-2', 'categories': [{'measurements': [{'value': '8.5', 'groupId': 'OG000', 'lowerLimit': '5.9', 'upperLimit': '8.5'}, {'value': '5.9', 'groupId': 'OG001', 'lowerLimit': '5.9', 'upperLimit': '8.5'}]}]}, {'title': 'IL-3', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '1.6'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '1.6'}]}]}, {'title': 'IL-4', 'categories': [{'measurements': [{'value': '9.4', 'groupId': 'OG000', 'lowerLimit': '9.4', 'upperLimit': '9.4'}, {'value': '9.4', 'groupId': 'OG001', 'lowerLimit': '9.4', 'upperLimit': '9.4'}]}]}, {'title': 'IL-5', 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000', 'lowerLimit': '2.7', 'upperLimit': '2.7'}, {'value': '2.7', 'groupId': 'OG001', 'lowerLimit': '2.7', 'upperLimit': '2.7'}]}]}, {'title': 'IL-6', 'categories': [{'measurements': [{'value': '3.6', 'groupId': 'OG000', 'lowerLimit': '1.7', 'upperLimit': '7.2'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '1.6'}]}]}, {'title': 'IL-6r', 'categories': [{'measurements': [{'value': '26000', 'groupId': 'OG000', 'lowerLimit': '17000', 'upperLimit': '33000'}, {'value': '24000', 'groupId': 'OG001', 'lowerLimit': '22000', 'upperLimit': '31000'}]}]}, {'title': 'IL-7', 'categories': [{'measurements': [{'value': '8.2', 'groupId': 'OG000', 'lowerLimit': '8.2', 'upperLimit': '8.2'}, {'value': '8.2', 'groupId': 'OG001', 'lowerLimit': '8.2', 'upperLimit': '8.2'}]}]}, {'title': 'IL-8', 'categories': [{'measurements': [{'value': '5.6', 'groupId': 'OG000', 'lowerLimit': '4.8', 'upperLimit': '7'}, {'value': '4.8', 'groupId': 'OG001', 'lowerLimit': '3.9', 'upperLimit': '5.9'}]}]}, {'title': 'IP-10', 'categories': [{'measurements': [{'value': '763', 'groupId': 'OG000', 'lowerLimit': '405', 'upperLimit': '1130'}, {'value': '212', 'groupId': 'OG001', 'lowerLimit': '197', 'upperLimit': '270'}]}]}, {'title': 'MCP-1', 'categories': [{'measurements': [{'value': '101', 'groupId': 'OG000', 'lowerLimit': '79', 'upperLimit': '137'}, {'value': '71', 'groupId': 'OG001', 'lowerLimit': '60', 'upperLimit': '93'}]}]}, {'title': 'MCP-2', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000', 'lowerLimit': '19', 'upperLimit': '67'}, {'value': '17', 'groupId': 'OG001', 'lowerLimit': '14', 'upperLimit': '19'}]}]}, {'title': 'MCP-4', 'categories': [{'measurements': [{'value': '1250', 'groupId': 'OG000', 'lowerLimit': '1090', 'upperLimit': '1400'}, {'value': '1090', 'groupId': 'OG001', 'lowerLimit': '912', 'upperLimit': '1330'}]}]}, {'title': 'MIG', 'categories': [{'measurements': [{'value': '763', 'groupId': 'OG000', 'lowerLimit': '604', 'upperLimit': '1260'}, {'value': '427', 'groupId': 'OG001', 'lowerLimit': '308', 'upperLimit': '597'}]}]}, {'title': 'MIP-1 alpha', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000', 'lowerLimit': '18', 'upperLimit': '21'}, {'value': '18', 'groupId': 'OG001', 'lowerLimit': '18', 'upperLimit': '18'}]}]}, {'title': 'MIP-1 beta', 'categories': [{'measurements': [{'value': '383', 'groupId': 'OG000', 'lowerLimit': '301', 'upperLimit': '540'}, {'value': '142', 'groupId': 'OG001', 'lowerLimit': '120', 'upperLimit': '176'}]}]}, {'title': 'MIP-3 alpha', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000', 'lowerLimit': '17', 'upperLimit': '25'}, {'value': '19', 'groupId': 'OG001', 'lowerLimit': '12', 'upperLimit': '28'}]}]}, {'title': 'MPIF-1', 'categories': [{'measurements': [{'value': '2000', 'groupId': 'OG000', 'lowerLimit': '1500', 'upperLimit': '2300'}, {'value': '1100', 'groupId': 'OG001', 'lowerLimit': '950', 'upperLimit': '1600'}]}]}, {'title': 'TNF-alpha', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000', 'lowerLimit': '13', 'upperLimit': '21'}, {'value': '13', 'groupId': 'OG001', 'lowerLimit': '13', 'upperLimit': '13'}]}]}, {'title': 'TNF-beta', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '3'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Post-dose 2 at Day 31', 'description': 'Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).'}, {'type': 'PRIMARY', 'title': 'Concentrations of Plasma Cytokines and Chemokines - Step 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HBsAg/AS_1 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}, {'id': 'OG001', 'title': 'Engerix-B_1 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}], 'classes': [{'title': 'E-selectin', 'categories': [{'measurements': [{'value': '7000', 'groupId': 'OG000', 'lowerLimit': '4400', 'upperLimit': '9100'}, {'value': '6000', 'groupId': 'OG001', 'lowerLimit': '4900', 'upperLimit': '8000'}]}]}, {'title': 'GM-CSF', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000', 'lowerLimit': '14', 'upperLimit': '14'}, {'value': '14', 'groupId': 'OG001', 'lowerLimit': '14', 'upperLimit': '14'}]}]}, {'title': 'IFN-γ', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '1.6'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '1.6'}]}]}, {'title': 'IL-10', 'categories': [{'measurements': [{'value': '3.5', 'groupId': 'OG000', 'lowerLimit': '3.3', 'upperLimit': '5.3'}, {'value': '3.3', 'groupId': 'OG001', 'lowerLimit': '3.3', 'upperLimit': '3.5'}]}]}, {'title': 'IL-18', 'categories': [{'measurements': [{'value': '238', 'groupId': 'OG000', 'lowerLimit': '195', 'upperLimit': '269'}, {'value': '190', 'groupId': 'OG001', 'lowerLimit': '135', 'upperLimit': '238'}]}]}, {'title': 'IL-2', 'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000', 'lowerLimit': '5.9', 'upperLimit': '7'}, {'value': '5.9', 'groupId': 'OG001', 'lowerLimit': '5.9', 'upperLimit': '7'}]}]}, {'title': 'IL-3', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '1.6'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '1.6'}]}]}, {'title': 'IL-4', 'categories': [{'measurements': [{'value': '9.4', 'groupId': 'OG000', 'lowerLimit': '9.4', 'upperLimit': '9.4'}, {'value': '9.4', 'groupId': 'OG001', 'lowerLimit': '9.4', 'upperLimit': '9.4'}]}]}, {'title': 'IL-5', 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000', 'lowerLimit': '2.7', 'upperLimit': '2.7'}, {'value': '2.7', 'groupId': 'OG001', 'lowerLimit': '2.7', 'upperLimit': '2.7'}]}]}, {'title': 'IL-6', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '2.5'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '1.6'}]}]}, {'title': 'IL-6r', 'categories': [{'measurements': [{'value': '27000', 'groupId': 'OG000', 'lowerLimit': '21000', 'upperLimit': '32000'}, {'value': '24000', 'groupId': 'OG001', 'lowerLimit': '21000', 'upperLimit': '31000'}]}]}, {'title': 'IL-7', 'categories': [{'measurements': [{'value': '8.2', 'groupId': 'OG000', 'lowerLimit': '8.2', 'upperLimit': '8.2'}, {'value': '8.2', 'groupId': 'OG001', 'lowerLimit': '8.2', 'upperLimit': '8.2'}]}]}, {'title': 'IL-8', 'categories': [{'measurements': [{'value': '5.5', 'groupId': 'OG000', 'lowerLimit': '4.3', 'upperLimit': '6.5'}, {'value': '5.1', 'groupId': 'OG001', 'lowerLimit': '4', 'upperLimit': '6.5'}]}]}, {'title': 'IP-10', 'categories': [{'measurements': [{'value': '760', 'groupId': 'OG000', 'lowerLimit': '492', 'upperLimit': '993'}, {'value': '226', 'groupId': 'OG001', 'lowerLimit': '192', 'upperLimit': '276'}]}]}, {'title': 'MCP-1', 'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000', 'lowerLimit': '55', 'upperLimit': '94'}, {'value': '77', 'groupId': 'OG001', 'lowerLimit': '65', 'upperLimit': '121'}]}]}, {'title': 'MCP-2', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000', 'lowerLimit': '17', 'upperLimit': '31'}, {'value': '21', 'groupId': 'OG001', 'lowerLimit': '17', 'upperLimit': '25'}]}]}, {'title': 'MCP-4', 'categories': [{'measurements': [{'value': '1350', 'groupId': 'OG000', 'lowerLimit': '1080', 'upperLimit': '1580'}, {'value': '1260', 'groupId': 'OG001', 'lowerLimit': '1010', 'upperLimit': '1560'}]}]}, {'title': 'MIG', 'categories': [{'measurements': [{'value': '850', 'groupId': 'OG000', 'lowerLimit': '667', 'upperLimit': '1070'}, {'value': '410', 'groupId': 'OG001', 'lowerLimit': '320', 'upperLimit': '581'}]}]}, {'title': 'MIP-1 alpha', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000', 'lowerLimit': '18', 'upperLimit': '19'}, {'value': '18', 'groupId': 'OG001', 'lowerLimit': '18', 'upperLimit': '23'}]}]}, {'title': 'MIP-1 beta', 'categories': [{'measurements': [{'value': '268', 'groupId': 'OG000', 'lowerLimit': '222', 'upperLimit': '307'}, {'value': '142', 'groupId': 'OG001', 'lowerLimit': '124', 'upperLimit': '171'}]}]}, {'title': 'MIP-3 alpha', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000', 'lowerLimit': '16', 'upperLimit': '30'}, {'value': '19', 'groupId': 'OG001', 'lowerLimit': '13', 'upperLimit': '28'}]}]}, {'title': 'MPIF-1', 'categories': [{'measurements': [{'value': '1800', 'groupId': 'OG000', 'lowerLimit': '1400', 'upperLimit': '2300'}, {'value': '1200', 'groupId': 'OG001', 'lowerLimit': '990', 'upperLimit': '1700'}]}]}, {'title': 'TNF-alpha', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000', 'lowerLimit': '13', 'upperLimit': '14'}, {'value': '13', 'groupId': 'OG001', 'lowerLimit': '13', 'upperLimit': '13'}]}]}, {'title': 'TNF-beta', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '3'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Post-dose 2 at Day 32', 'description': 'Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).'}, {'type': 'PRIMARY', 'title': 'Concentrations of Plasma Cytokines and Chemokines in Step 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HBsAg/AS_1 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}, {'id': 'OG001', 'title': 'Engerix-B_1 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}], 'classes': [{'title': 'E-selectin', 'categories': [{'measurements': [{'value': '6400', 'groupId': 'OG000', 'lowerLimit': '4400', 'upperLimit': '8700'}, {'value': '6300', 'groupId': 'OG001', 'lowerLimit': '5100', 'upperLimit': '8000'}]}]}, {'title': 'GM-CSF', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000', 'lowerLimit': '14', 'upperLimit': '14'}, {'value': '14', 'groupId': 'OG001', 'lowerLimit': '14', 'upperLimit': '14'}]}]}, {'title': 'IFN-γ', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '1.6'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '1.6'}]}]}, {'title': 'IL-10', 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000', 'lowerLimit': '3.3', 'upperLimit': '3.6'}, {'value': '3.3', 'groupId': 'OG001', 'lowerLimit': '3.3', 'upperLimit': '3.6'}]}]}, {'title': 'IL-18', 'categories': [{'measurements': [{'value': '256', 'groupId': 'OG000', 'lowerLimit': '195', 'upperLimit': '351'}, {'value': '181', 'groupId': 'OG001', 'lowerLimit': '142', 'upperLimit': '231'}]}]}, {'title': 'IL-2', 'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000', 'lowerLimit': '5.9', 'upperLimit': '5.9'}, {'value': '5.9', 'groupId': 'OG001', 'lowerLimit': '5.9', 'upperLimit': '5.9'}]}]}, {'title': 'IL-3', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '1.6'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '1.6'}]}]}, {'title': 'IL-4', 'categories': [{'measurements': [{'value': '9.4', 'groupId': 'OG000', 'lowerLimit': '9.4', 'upperLimit': '9.4'}, {'value': '9.4', 'groupId': 'OG001', 'lowerLimit': '9.4', 'upperLimit': '9.4'}]}]}, {'title': 'IL-5', 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000', 'lowerLimit': '2.7', 'upperLimit': '2.7'}, {'value': '2.7', 'groupId': 'OG001', 'lowerLimit': '2.7', 'upperLimit': '2.7'}]}]}, {'title': 'IL-6', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '1.6'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '1.6'}]}]}, {'title': 'IL-6r', 'categories': [{'measurements': [{'value': '26000', 'groupId': 'OG000', 'lowerLimit': '21000', 'upperLimit': '33000'}, {'value': '25000', 'groupId': 'OG001', 'lowerLimit': '21000', 'upperLimit': '28000'}]}]}, {'title': 'IL-7', 'categories': [{'measurements': [{'value': '8.2', 'groupId': 'OG000', 'lowerLimit': '8.2', 'upperLimit': '8.2'}, {'value': '8.2', 'groupId': 'OG001', 'lowerLimit': '8.2', 'upperLimit': '8.2'}]}]}, {'title': 'IL-8', 'categories': [{'measurements': [{'value': '5.5', 'groupId': 'OG000', 'lowerLimit': '4.3', 'upperLimit': '7.4'}, {'value': '5.5', 'groupId': 'OG001', 'lowerLimit': '4.3', 'upperLimit': '6.2'}]}]}, {'title': 'IP-10', 'categories': [{'measurements': [{'value': '366', 'groupId': 'OG000', 'lowerLimit': '288', 'upperLimit': '524'}, {'value': '249', 'groupId': 'OG001', 'lowerLimit': '220', 'upperLimit': '319'}]}]}, {'title': 'MCP-1', 'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000', 'lowerLimit': '65', 'upperLimit': '101'}, {'value': '93', 'groupId': 'OG001', 'lowerLimit': '77', 'upperLimit': '131'}]}]}, {'title': 'MCP-2', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000', 'lowerLimit': '16', 'upperLimit': '28'}, {'value': '20', 'groupId': 'OG001', 'lowerLimit': '17', 'upperLimit': '26'}]}]}, {'title': 'MCP-4', 'categories': [{'measurements': [{'value': '1390', 'groupId': 'OG000', 'lowerLimit': '1190', 'upperLimit': '1600'}, {'value': '1280', 'groupId': 'OG001', 'lowerLimit': '1090', 'upperLimit': '1600'}]}]}, {'title': 'MIG', 'categories': [{'measurements': [{'value': '796', 'groupId': 'OG000', 'lowerLimit': '586', 'upperLimit': '908'}, {'value': '537', 'groupId': 'OG001', 'lowerLimit': '456', 'upperLimit': '722'}]}]}, {'title': 'MIP-1 alpha', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000', 'lowerLimit': '18', 'upperLimit': '24'}, {'value': '19', 'groupId': 'OG001', 'lowerLimit': '18', 'upperLimit': '22'}]}]}, {'title': 'MIP-1 beta', 'categories': [{'measurements': [{'value': '241', 'groupId': 'OG000', 'lowerLimit': '175', 'upperLimit': '279'}, {'value': '163', 'groupId': 'OG001', 'lowerLimit': '135', 'upperLimit': '201'}]}]}, {'title': 'MIP-3 alpha', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000', 'lowerLimit': '21', 'upperLimit': '40'}, {'value': '25', 'groupId': 'OG001', 'lowerLimit': '21', 'upperLimit': '32'}]}]}, {'title': 'MPIF-1', 'categories': [{'measurements': [{'value': '1800', 'groupId': 'OG000', 'lowerLimit': '1400', 'upperLimit': '2200'}, {'value': '1300', 'groupId': 'OG001', 'lowerLimit': '1100', 'upperLimit': '1600'}]}]}, {'title': 'TNF-alpha', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000', 'lowerLimit': '13', 'upperLimit': '13'}, {'value': '13', 'groupId': 'OG001', 'lowerLimit': '13', 'upperLimit': '13'}]}]}, {'title': 'TNF-beta', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '3'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '3.4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Post-dose 2 at Day 33', 'description': 'Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).'}, {'type': 'PRIMARY', 'title': 'Concentrations of Plasma Cytokines and Chemokines During Step 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HBsAg/AS_1 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}, {'id': 'OG001', 'title': 'Engerix-B_1 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}], 'classes': [{'title': 'E-selectin', 'categories': [{'measurements': [{'value': '6200', 'groupId': 'OG000', 'lowerLimit': '4000', 'upperLimit': '8200'}, {'value': '6000', 'groupId': 'OG001', 'lowerLimit': '5000', 'upperLimit': '7700'}]}]}, {'title': 'GM-CSF', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000', 'lowerLimit': '14', 'upperLimit': '14'}, {'value': '14', 'groupId': 'OG001', 'lowerLimit': '14', 'upperLimit': '14'}]}]}, {'title': 'IFN-γ', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '1.6'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '1.6'}]}]}, {'title': 'IL-10', 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000', 'lowerLimit': '3.3', 'upperLimit': '3.3'}, {'value': '3.3', 'groupId': 'OG001', 'lowerLimit': '3.3', 'upperLimit': '3.3'}]}]}, {'title': 'IL-18', 'categories': [{'measurements': [{'value': '194', 'groupId': 'OG000', 'lowerLimit': '156', 'upperLimit': '256'}, {'value': '166', 'groupId': 'OG001', 'lowerLimit': '123', 'upperLimit': '196'}]}]}, {'title': 'IL-2', 'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000', 'lowerLimit': '5.9', 'upperLimit': '5.9'}, {'value': '5.9', 'groupId': 'OG001', 'lowerLimit': '5.9', 'upperLimit': '5.9'}]}]}, {'title': 'IL-3', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '1.6'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '1.6'}]}]}, {'title': 'IL-4', 'categories': [{'measurements': [{'value': '9.4', 'groupId': 'OG000', 'lowerLimit': '9.4', 'upperLimit': '9.4'}, {'value': '9.4', 'groupId': 'OG001', 'lowerLimit': '9.4', 'upperLimit': '9.4'}]}]}, {'title': 'IL-5', 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000', 'lowerLimit': '2.7', 'upperLimit': '2.7'}, {'value': '2.7', 'groupId': 'OG001', 'lowerLimit': '2.7', 'upperLimit': '2.7'}]}]}, {'title': 'IL-6', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '1.6'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '1.6'}]}]}, {'title': 'IL-6r', 'categories': [{'measurements': [{'value': '28000', 'groupId': 'OG000', 'lowerLimit': '16000', 'upperLimit': '35000'}, {'value': '25000', 'groupId': 'OG001', 'lowerLimit': '20000', 'upperLimit': '27000'}]}]}, {'title': 'IL-7', 'categories': [{'measurements': [{'value': '8.2', 'groupId': 'OG000', 'lowerLimit': '8.2', 'upperLimit': '8.2'}, {'value': '8.2', 'groupId': 'OG001', 'lowerLimit': '8.2', 'upperLimit': '8.2'}]}]}, {'title': 'IL-8', 'categories': [{'measurements': [{'value': '5.3', 'groupId': 'OG000', 'lowerLimit': '3.9', 'upperLimit': '6.6'}, {'value': '5.5', 'groupId': 'OG001', 'lowerLimit': '4.6', 'upperLimit': '6'}]}]}, {'title': 'IP-10', 'categories': [{'measurements': [{'value': '259', 'groupId': 'OG000', 'lowerLimit': '213', 'upperLimit': '296'}, {'value': '223', 'groupId': 'OG001', 'lowerLimit': '179', 'upperLimit': '289'}]}]}, {'title': 'MCP-1', 'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000', 'lowerLimit': '66', 'upperLimit': '109'}, {'value': '85', 'groupId': 'OG001', 'lowerLimit': '63', 'upperLimit': '99'}]}]}, {'title': 'MCP-2', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000', 'lowerLimit': '13', 'upperLimit': '23'}, {'value': '20', 'groupId': 'OG001', 'lowerLimit': '16', 'upperLimit': '24'}]}]}, {'title': 'MCP-4', 'categories': [{'measurements': [{'value': '1220', 'groupId': 'OG000', 'lowerLimit': '1110', 'upperLimit': '1480'}, {'value': '1210', 'groupId': 'OG001', 'lowerLimit': '1010', 'upperLimit': '1340'}]}]}, {'title': 'MIG', 'categories': [{'measurements': [{'value': '447', 'groupId': 'OG000', 'lowerLimit': '398', 'upperLimit': '535'}, {'value': '364', 'groupId': 'OG001', 'lowerLimit': '284', 'upperLimit': '472'}]}]}, {'title': 'MIP-1 alpha', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000', 'lowerLimit': '18', 'upperLimit': '23'}, {'value': '18', 'groupId': 'OG001', 'lowerLimit': '18', 'upperLimit': '19'}]}]}, {'title': 'MIP-1 beta', 'categories': [{'measurements': [{'value': '150', 'groupId': 'OG000', 'lowerLimit': '119', 'upperLimit': '190'}, {'value': '151', 'groupId': 'OG001', 'lowerLimit': '126', 'upperLimit': '175'}]}]}, {'title': 'MIP-3 alpha', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000', 'lowerLimit': '15', 'upperLimit': '28'}, {'value': '18', 'groupId': 'OG001', 'lowerLimit': '15', 'upperLimit': '24'}]}]}, {'title': 'MPIF-1', 'categories': [{'measurements': [{'value': '1600', 'groupId': 'OG000', 'lowerLimit': '1200', 'upperLimit': '1800'}, {'value': '1300', 'groupId': 'OG001', 'lowerLimit': '1000', 'upperLimit': '1400'}]}]}, {'title': 'TNF-alpha', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000', 'lowerLimit': '13', 'upperLimit': '13'}, {'value': '13', 'groupId': 'OG001', 'lowerLimit': '13', 'upperLimit': '13'}]}]}, {'title': 'TNF-beta', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '3'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Post-dose 2 at Day 37', 'description': 'Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).'}, {'type': 'PRIMARY', 'title': 'Concentrations of Cytokines and Chemokines - Step 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HBsAg/AS_2 Group', 'description': 'Subjects received, during Step 2 of the study, 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm'}, {'id': 'OG001', 'title': 'Engerix-B_2 Group', 'description': 'Subjects received, during Step 2 of the study, 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}], 'classes': [{'title': 'E-selectin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8100', 'groupId': 'OG000', 'lowerLimit': '4200', 'upperLimit': '8900'}, {'value': '5400', 'groupId': 'OG001', 'lowerLimit': '4400', 'upperLimit': '5500'}]}]}, {'title': 'GM-CSF', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000', 'lowerLimit': '14', 'upperLimit': '14'}, {'value': '14', 'groupId': 'OG001', 'lowerLimit': '14', 'upperLimit': '14'}]}]}, {'title': 'IFN-γ', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '1.6'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '1.6'}]}]}, {'title': 'IL-10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000', 'lowerLimit': '3.3', 'upperLimit': '3.8'}, {'value': '3.3', 'groupId': 'OG001', 'lowerLimit': '3.3', 'upperLimit': '3.3'}]}]}, {'title': 'IL-18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '199.5', 'groupId': 'OG000', 'lowerLimit': '175', 'upperLimit': '377'}, {'value': '179', 'groupId': 'OG001', 'lowerLimit': '152', 'upperLimit': '182'}]}]}, {'title': 'IL-2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000', 'lowerLimit': '5.9', 'upperLimit': '5.9'}, {'value': '5.9', 'groupId': 'OG001', 'lowerLimit': '5.9', 'upperLimit': '5.9'}]}]}, {'title': 'IL-3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '1.6'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '1.6'}]}]}, {'title': 'IL-4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.4', 'groupId': 'OG000', 'lowerLimit': '9.4', 'upperLimit': '9.4'}, {'value': '9.4', 'groupId': 'OG001', 'lowerLimit': '9.4', 'upperLimit': '9.4'}]}]}, {'title': 'IL-5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000', 'lowerLimit': '2.7', 'upperLimit': '2.7'}, {'value': '2.7', 'groupId': 'OG001', 'lowerLimit': '2.7', 'upperLimit': '2.7'}]}]}, {'title': 'IL-6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '1.6'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '1.6'}]}]}, {'title': 'IL-6r', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '32000', 'groupId': 'OG000', 'lowerLimit': '29000', 'upperLimit': '36000'}, {'value': '30000', 'groupId': 'OG001', 'lowerLimit': '28000', 'upperLimit': '36000'}]}]}, {'title': 'IL-7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.2', 'groupId': 'OG000', 'lowerLimit': '8.2', 'upperLimit': '8.2'}, {'value': '8.2', 'groupId': 'OG001', 'lowerLimit': '8.2', 'upperLimit': '8.2'}]}]}, {'title': 'IL-8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.3', 'groupId': 'OG000', 'lowerLimit': '3.5', 'upperLimit': '11'}, {'value': '4.4', 'groupId': 'OG001', 'lowerLimit': '3.5', 'upperLimit': '6.2'}]}]}, {'title': 'IP-10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '300.5', 'groupId': 'OG000', 'lowerLimit': '275', 'upperLimit': '370'}, {'value': '234', 'groupId': 'OG001', 'lowerLimit': '166', 'upperLimit': '278'}]}]}, {'title': 'MCP-1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '86.5', 'groupId': 'OG000', 'lowerLimit': '77', 'upperLimit': '132'}, {'value': '87', 'groupId': 'OG001', 'lowerLimit': '67', 'upperLimit': '96'}]}]}, {'title': 'MCP-2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22.5', 'groupId': 'OG000', 'lowerLimit': '17', 'upperLimit': '27'}, {'value': '27', 'groupId': 'OG001', 'lowerLimit': '19', 'upperLimit': '30'}]}]}, {'title': 'MCP-4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1805', 'groupId': 'OG000', 'lowerLimit': '1300', 'upperLimit': '2010'}, {'value': '2120', 'groupId': 'OG001', 'lowerLimit': '1720', 'upperLimit': '2260'}]}]}, {'title': 'MIG', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'MIP-1 alpha', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000', 'lowerLimit': '18', 'upperLimit': '18'}, {'value': '18', 'groupId': 'OG001', 'lowerLimit': '18', 'upperLimit': '18'}]}]}, {'title': 'MIP-1 beta', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '234', 'groupId': 'OG000', 'lowerLimit': '186', 'upperLimit': '255'}, {'value': '253', 'groupId': 'OG001', 'lowerLimit': '200', 'upperLimit': '300'}]}]}, {'title': 'MIP-3 alpha', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '28.5', 'groupId': 'OG000', 'lowerLimit': '23', 'upperLimit': '64'}, {'value': '29', 'groupId': 'OG001', 'lowerLimit': '17', 'upperLimit': '42'}]}]}, {'title': 'MPIF-1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1095', 'groupId': 'OG000', 'lowerLimit': '820', 'upperLimit': '1200'}, {'value': '1100', 'groupId': 'OG001', 'lowerLimit': '930', 'upperLimit': '1200'}]}]}, {'title': 'TNF-alpha', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000', 'lowerLimit': '13', 'upperLimit': '13'}, {'value': '13', 'groupId': 'OG001', 'lowerLimit': '13', 'upperLimit': '13'}]}]}, {'title': 'TNF-beta', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '3'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-dose 1 at Day 0', 'description': 'Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to 30 days post last vaccination (step 2 only), which included all evaluable subjects, who complied with the protocol, and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point.'}, {'type': 'PRIMARY', 'title': 'Cytokines and Chemokines Concentrations - Step 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HBsAg/AS_2 Group', 'description': 'Subjects received, during Step 2 of the study, 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm'}], 'classes': [{'title': 'E-selectin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7900', 'groupId': 'OG000', 'lowerLimit': '4300', 'upperLimit': '9100'}]}]}, {'title': 'GM-CSF', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000', 'lowerLimit': '14', 'upperLimit': '14'}]}]}, {'title': 'IFN-γ', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '1.6'}]}]}, {'title': 'IL-10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.8', 'groupId': 'OG000', 'lowerLimit': '3.3', 'upperLimit': '4.7'}]}]}, {'title': 'IL-18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '206', 'groupId': 'OG000', 'lowerLimit': '182', 'upperLimit': '260'}]}]}, {'title': 'IL-2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000', 'lowerLimit': '5.9', 'upperLimit': '5.9'}]}]}, {'title': 'IL-3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '1.6'}]}]}, {'title': 'IL-4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.4', 'groupId': 'OG000', 'lowerLimit': '9.4', 'upperLimit': '9.4'}]}]}, {'title': 'IL-5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000', 'lowerLimit': '2.7', 'upperLimit': '2.7'}]}]}, {'title': 'IL-6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '2.6'}]}]}, {'title': 'IL-6r', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '24000', 'groupId': 'OG000', 'lowerLimit': '22000', 'upperLimit': '33000'}]}]}, {'title': 'IL-7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.2', 'groupId': 'OG000', 'lowerLimit': '8.2', 'upperLimit': '8.2'}]}]}, {'title': 'IL-8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.9', 'groupId': 'OG000', 'lowerLimit': '2.6', 'upperLimit': '7.1'}]}]}, {'title': 'IP-10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '294', 'groupId': 'OG000', 'lowerLimit': '199', 'upperLimit': '390'}]}]}, {'title': 'MCP-1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000', 'lowerLimit': '27', 'upperLimit': '114'}]}]}, {'title': 'MCP-2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000', 'lowerLimit': '20', 'upperLimit': '29'}]}]}, {'title': 'MCP-4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1240', 'groupId': 'OG000', 'lowerLimit': '1130', 'upperLimit': '1640'}]}]}, {'title': 'MIG', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'MIP-1 alpha', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000', 'lowerLimit': '18', 'upperLimit': '32'}]}]}, {'title': 'MIP-1 beta', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '318', 'groupId': 'OG000', 'lowerLimit': '241', 'upperLimit': '391'}]}]}, {'title': 'MIP-3 alpha', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000', 'lowerLimit': '17', 'upperLimit': '46'}]}]}, {'title': 'MPIF-1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1400', 'groupId': 'OG000', 'lowerLimit': '1200', 'upperLimit': '1500'}]}]}, {'title': 'TNF-alpha', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000', 'lowerLimit': '13', 'upperLimit': '13'}]}]}, {'title': 'TNF-beta', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Post-dose 1 at Day 1', 'description': 'Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma. The analysis was performed only on the HBsAg/AS\\_2 Group.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to 30 days post last vaccination (step 2 only), which included all evaluable subjects, who complied with the protocol, and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point.'}, {'type': 'PRIMARY', 'title': 'Concentrations of Cytokines and Chemokines During Step 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HBsAg/AS_2 Group', 'description': 'Subjects received, during Step 2 of the study, 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm'}], 'classes': [{'title': 'E-selectin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6200', 'groupId': 'OG000', 'lowerLimit': '3600', 'upperLimit': '8450'}]}]}, {'title': 'GM-CSF', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000', 'lowerLimit': '14', 'upperLimit': '14'}]}]}, {'title': 'IFN-γ', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '1.6'}]}]}, {'title': 'IL-10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000', 'lowerLimit': '3.3', 'upperLimit': '3.6'}]}]}, {'title': 'IL-18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '166.5', 'groupId': 'OG000', 'lowerLimit': '132.5', 'upperLimit': '271.5'}]}]}, {'title': 'IL-2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000', 'lowerLimit': '5.9', 'upperLimit': '5.9'}]}]}, {'title': 'IL-3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '1.6'}]}]}, {'title': 'IL-4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.4', 'groupId': 'OG000', 'lowerLimit': '9.4', 'upperLimit': '11.2'}]}]}, {'title': 'IL-5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000', 'lowerLimit': '2.7', 'upperLimit': '2.7'}]}]}, {'title': 'IL-6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '1.7'}]}]}, {'title': 'IL-6r', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '29000', 'groupId': 'OG000', 'lowerLimit': '24500', 'upperLimit': '33500'}]}]}, {'title': 'IL-7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.2', 'groupId': 'OG000', 'lowerLimit': '8.2', 'upperLimit': '10.1'}]}]}, {'title': 'IL-8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.3', 'groupId': 'OG000', 'lowerLimit': '3.1', 'upperLimit': '8.4'}]}]}, {'title': 'IP-10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '231.5', 'groupId': 'OG000', 'lowerLimit': '160.5', 'upperLimit': '318.5'}]}]}, {'title': 'MCP-1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000', 'lowerLimit': '35', 'upperLimit': '115.5'}]}]}, {'title': 'MCP-2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '19.5', 'groupId': 'OG000', 'lowerLimit': '17', 'upperLimit': '20.5'}]}]}, {'title': 'MCP-4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1340', 'groupId': 'OG000', 'lowerLimit': '1115', 'upperLimit': '1450'}]}]}, {'title': 'MIG', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'MIP-1 alpha', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000', 'lowerLimit': '18', 'upperLimit': '18'}]}]}, {'title': 'MIP-1 beta', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '172', 'groupId': 'OG000', 'lowerLimit': '158.5', 'upperLimit': '196.5'}]}]}, {'title': 'MIP-3 alpha', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000', 'lowerLimit': '15', 'upperLimit': '30.5'}]}]}, {'title': 'MPIF-1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1200', 'groupId': 'OG000', 'lowerLimit': '855', 'upperLimit': '1400'}]}]}, {'title': 'TNF-alpha', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000', 'lowerLimit': '13', 'upperLimit': '13'}]}]}, {'title': 'TNF-beta', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Post-dose 1 at Day 30', 'description': 'Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma. The analysis was performed only on the HBsAg/AS\\_2 Group.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to 30 days post last vaccination (step 2 only), which included all evaluable subjects, who complied with the protocol, and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point.'}, {'type': 'PRIMARY', 'title': 'Concentrations of Cytokines and Chemokines in Step 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HBsAg/AS_2 Group', 'description': 'Subjects received, during Step 2 of the study, 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm'}], 'classes': [{'title': 'E-selectin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5400', 'groupId': 'OG000', 'lowerLimit': '3400', 'upperLimit': '8300'}]}]}, {'title': 'GM-CSF', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000', 'lowerLimit': '14', 'upperLimit': '14'}]}]}, {'title': 'IFN-γ', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '1.6'}]}]}, {'title': 'IL-10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000', 'lowerLimit': '3.3', 'upperLimit': '3.3'}]}]}, {'title': 'IL-18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '172', 'groupId': 'OG000', 'lowerLimit': '150', 'upperLimit': '247'}]}]}, {'title': 'IL-2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000', 'lowerLimit': '5.9', 'upperLimit': '5.9'}]}]}, {'title': 'IL-3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '1.6'}]}]}, {'title': 'IL-4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.4', 'groupId': 'OG000', 'lowerLimit': '9.4', 'upperLimit': '10'}]}]}, {'title': 'IL-5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000', 'lowerLimit': '2.7', 'upperLimit': '2.7'}]}]}, {'title': 'IL-6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.7', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '4.7'}]}]}, {'title': 'IL-6r', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '34000', 'groupId': 'OG000', 'lowerLimit': '27000', 'upperLimit': '43000'}]}]}, {'title': 'IL-7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000', 'lowerLimit': '8.2', 'upperLimit': '21'}]}]}, {'title': 'IL-8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.1', 'groupId': 'OG000', 'lowerLimit': '3.6', 'upperLimit': '9.1'}]}]}, {'title': 'IP-10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '163', 'groupId': 'OG000', 'lowerLimit': '128', 'upperLimit': '205'}]}]}, {'title': 'MCP-1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000', 'lowerLimit': '27', 'upperLimit': '86'}]}]}, {'title': 'MCP-2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000', 'lowerLimit': '18', 'upperLimit': '25'}]}]}, {'title': 'MCP-4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1330', 'groupId': 'OG000', 'lowerLimit': '979', 'upperLimit': '1540'}]}]}, {'title': 'MIG', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'MIP-1 alpha', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000', 'lowerLimit': '18', 'upperLimit': '18'}]}]}, {'title': 'MIP-1 beta', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '182', 'groupId': 'OG000', 'lowerLimit': '154', 'upperLimit': '266'}]}]}, {'title': 'MIP-3 alpha', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000', 'lowerLimit': '13', 'upperLimit': '28'}]}]}, {'title': 'MPIF-1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1300', 'groupId': 'OG000', 'lowerLimit': '980', 'upperLimit': '1700'}]}]}, {'title': 'TNF-alpha', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000', 'lowerLimit': '13', 'upperLimit': '13'}]}]}, {'title': 'TNF-beta', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '6.3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Post-dose2 at Day 30 plus 6 Hours', 'description': 'Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma. The analysis was performed only on the HBsAg/AS\\_2 Group.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to 30 days post last vaccination (step 2 only), which included all evaluable subjects, who complied with the protocol, and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point.'}, {'type': 'PRIMARY', 'title': 'Concentrations of Cytokines/Chemokines - Step 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HBsAg/AS_2 Group', 'description': 'Subjects received, during Step 2 of the study, 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm'}], 'classes': [{'title': 'E-selectin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7450', 'groupId': 'OG000', 'lowerLimit': '4600', 'upperLimit': '10500'}]}]}, {'title': 'GM-CSF', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000', 'lowerLimit': '14', 'upperLimit': '14'}]}]}, {'title': 'IFN-γ', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.2', 'groupId': 'OG000', 'lowerLimit': '3.4', 'upperLimit': '17.6'}]}]}, {'title': 'IL-10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000', 'lowerLimit': '3.3', 'upperLimit': '4.4'}]}]}, {'title': 'IL-18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '234', 'groupId': 'OG000', 'lowerLimit': '181', 'upperLimit': '339.5'}]}]}, {'title': 'IL-2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000', 'lowerLimit': '5.9', 'upperLimit': '5.9'}]}]}, {'title': 'IL-3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '1.6'}]}]}, {'title': 'IL-4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.7', 'groupId': 'OG000', 'lowerLimit': '9.4', 'upperLimit': '10'}]}]}, {'title': 'IL-5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000', 'lowerLimit': '2.7', 'upperLimit': '2.7'}]}]}, {'title': 'IL-6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '2.2', 'upperLimit': '5.7'}]}]}, {'title': 'IL-6r', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '30500', 'groupId': 'OG000', 'lowerLimit': '27000', 'upperLimit': '41500'}]}]}, {'title': 'IL-7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10.1', 'groupId': 'OG000', 'lowerLimit': '8.2', 'upperLimit': '23.5'}]}]}, {'title': 'IL-8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.9', 'groupId': 'OG000', 'lowerLimit': '7.3', 'upperLimit': '10.9'}]}]}, {'title': 'IP-10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '737.5', 'groupId': 'OG000', 'lowerLimit': '510', 'upperLimit': '1270'}]}]}, {'title': 'MCP-1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '142.5', 'groupId': 'OG000', 'lowerLimit': '104', 'upperLimit': '153'}]}]}, {'title': 'MCP-2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '40.5', 'groupId': 'OG000', 'lowerLimit': '32', 'upperLimit': '72.5'}]}]}, {'title': 'MCP-4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1330', 'groupId': 'OG000', 'lowerLimit': '974', 'upperLimit': '1780'}]}]}, {'title': 'MIG', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'MIP-1 alpha', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000', 'lowerLimit': '18', 'upperLimit': '18'}]}]}, {'title': 'MIP-1 beta', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '580', 'groupId': 'OG000', 'lowerLimit': '359.5', 'upperLimit': '780.5'}]}]}, {'title': 'MIP-3 alpha', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000', 'lowerLimit': '19', 'upperLimit': '39.5'}]}]}, {'title': 'MPIF-1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1750', 'groupId': 'OG000', 'lowerLimit': '1500', 'upperLimit': '1850'}]}]}, {'title': 'TNF-alpha', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000', 'lowerLimit': '13', 'upperLimit': '13'}]}]}, {'title': 'TNF-beta', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Post-dose 2 at Day 31', 'description': 'Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma. The analysis was performed only on the HBsAg/AS\\_2 Group.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to 30 days post last vaccination (step 2 only), which included all evaluable subjects, who complied with the protocol, and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point.'}, {'type': 'PRIMARY', 'title': 'Concentrations of Cytokines/Chemokines in Step 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HBsAg/AS_2 Group', 'description': 'Subjects received, during Step 2 of the study, 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm'}], 'classes': [{'title': 'E-selectin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6550', 'groupId': 'OG000', 'lowerLimit': '3250', 'upperLimit': '8450'}]}]}, {'title': 'GM-CSF', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000', 'lowerLimit': '14', 'upperLimit': '14'}]}]}, {'title': 'IFN-γ', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '1.6'}]}]}, {'title': 'IL-10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000', 'lowerLimit': '3.3', 'upperLimit': '3.8'}]}]}, {'title': 'IL-18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '232', 'groupId': 'OG000', 'lowerLimit': '145.5', 'upperLimit': '322'}]}]}, {'title': 'IL-2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000', 'lowerLimit': '5.9', 'upperLimit': '5.9'}]}]}, {'title': 'IL-3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '1.6'}]}]}, {'title': 'IL-4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.7', 'groupId': 'OG000', 'lowerLimit': '9.4', 'upperLimit': '14'}]}]}, {'title': 'IL-5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000', 'lowerLimit': '2.7', 'upperLimit': '2.7'}]}]}, {'title': 'IL-6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '1.7'}]}]}, {'title': 'IL-6r', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '28000', 'groupId': 'OG000', 'lowerLimit': '26500', 'upperLimit': '34500'}]}]}, {'title': 'IL-7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.2', 'groupId': 'OG000', 'lowerLimit': '8.2', 'upperLimit': '8.2'}]}]}, {'title': 'IL-8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.5', 'groupId': 'OG000', 'lowerLimit': '6.7', 'upperLimit': '9.7'}]}]}, {'title': 'IP-10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '170', 'groupId': 'OG000', 'lowerLimit': '143', 'upperLimit': '210'}]}]}, {'title': 'MCP-1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '72.5', 'groupId': 'OG000', 'lowerLimit': '27', 'upperLimit': '104'}]}]}, {'title': 'MCP-2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '18.5', 'groupId': 'OG000', 'lowerLimit': '15', 'upperLimit': '23'}]}]}, {'title': 'MCP-4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1275', 'groupId': 'OG000', 'lowerLimit': '881.5', 'upperLimit': '1635'}]}]}, {'title': 'MIG', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'MIP-1 alpha', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000', 'lowerLimit': '18', 'upperLimit': '18'}]}]}, {'title': 'MIP-1 beta', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '174', 'groupId': 'OG000', 'lowerLimit': '152.5', 'upperLimit': '187.5'}]}]}, {'title': 'MIP-3 alpha', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000', 'lowerLimit': '11.5', 'upperLimit': '94'}]}]}, {'title': 'MPIF-1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1100', 'groupId': 'OG000', 'lowerLimit': '995', 'upperLimit': '1450'}]}]}, {'title': 'TNF-alpha', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000', 'lowerLimit': '13', 'upperLimit': '13'}]}]}, {'title': 'TNF-beta', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '11.2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Post-dose 2 at Day 37', 'description': 'Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.\n\nThe analysis was performed only on the HBsAg/AS\\_2 Group.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to 30 days post last vaccination (step 2 only), which included all evaluable subjects, who complied with the protocol, and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point.'}, {'type': 'PRIMARY', 'title': 'Concentrations of Cytokines/Chemokines During Step 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Engerix-B_2 Group', 'description': 'Subjects received, during Step 2 of the study, 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}], 'classes': [{'title': 'E-selectin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4900', 'groupId': 'OG000', 'lowerLimit': '4300', 'upperLimit': '5800'}]}]}, {'title': 'GM-CSF', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000', 'lowerLimit': '14', 'upperLimit': '14'}]}]}, {'title': 'IFN-γ', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '1.6'}]}]}, {'title': 'IL-10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000', 'lowerLimit': '3.3', 'upperLimit': '3.3'}]}]}, {'title': 'IL-18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '159', 'groupId': 'OG000', 'lowerLimit': '144', 'upperLimit': '190'}]}]}, {'title': 'IL-2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000', 'lowerLimit': '5.9', 'upperLimit': '5.9'}]}]}, {'title': 'IL-3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '1.6'}]}]}, {'title': 'IL-4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.4', 'groupId': 'OG000', 'lowerLimit': '9.4', 'upperLimit': '9.4'}]}]}, {'title': 'IL-5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000', 'lowerLimit': '2.7', 'upperLimit': '2.7'}]}]}, {'title': 'IL-6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '1.6'}]}]}, {'title': 'IL-6r', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '24000', 'groupId': 'OG000', 'lowerLimit': '24000', 'upperLimit': '32000'}]}]}, {'title': 'IL-7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.2', 'groupId': 'OG000', 'lowerLimit': '8.2', 'upperLimit': '8.2'}]}]}, {'title': 'IL-8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.4', 'groupId': 'OG000', 'lowerLimit': '3.5', 'upperLimit': '5.3'}]}]}, {'title': 'IP-10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '156', 'groupId': 'OG000', 'lowerLimit': '121', 'upperLimit': '260'}]}]}, {'title': 'MCP-1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '77', 'groupId': 'OG000', 'lowerLimit': '57', 'upperLimit': '77'}]}]}, {'title': 'MCP-2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000', 'lowerLimit': '14', 'upperLimit': '27'}]}]}, {'title': 'MCP-4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1640', 'groupId': 'OG000', 'lowerLimit': '1540', 'upperLimit': '1810'}]}]}, {'title': 'MIG', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'MIP-1 alpha', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000', 'lowerLimit': '18', 'upperLimit': '18'}]}]}, {'title': 'MIP-1 beta', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '189', 'groupId': 'OG000', 'lowerLimit': '177', 'upperLimit': '257'}]}]}, {'title': 'MIP-3 alpha', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000', 'lowerLimit': '13', 'upperLimit': '32'}]}]}, {'title': 'MPIF-1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '920', 'groupId': 'OG000', 'lowerLimit': '830', 'upperLimit': '970'}]}]}, {'title': 'TNF-alpha', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000', 'lowerLimit': '13', 'upperLimit': '13'}]}]}, {'title': 'TNF-beta', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Post-dose 2 at Day 180', 'description': 'Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.\n\nThe analysis was performed only on the Engerix-B\\_2 Group.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to 30 days post last vaccination (step 2 only), which included all evaluable subjects, who complied with the protocol, and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point.'}, {'type': 'PRIMARY', 'title': 'Plasma Concentrations of Cytokines and Chemokines - Study Step 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Engerix-B_2 Group', 'description': 'Subjects received, during Step 2 of the study, 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}], 'classes': [{'title': 'E-selectin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4600', 'groupId': 'OG000', 'lowerLimit': '4100', 'upperLimit': '5800'}]}]}, {'title': 'GM-CSF', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000', 'lowerLimit': '14', 'upperLimit': '14'}]}]}, {'title': 'IFN-γ', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '1.6'}]}]}, {'title': 'IL-10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000', 'lowerLimit': '3.3', 'upperLimit': '3.3'}]}]}, {'title': 'IL-18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '144', 'groupId': 'OG000', 'lowerLimit': '133', 'upperLimit': '152'}]}]}, {'title': 'IL-2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000', 'lowerLimit': '5.9', 'upperLimit': '5.9'}]}]}, {'title': 'IL-3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '1.6'}]}]}, {'title': 'IL-4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.4', 'groupId': 'OG000', 'lowerLimit': '9.4', 'upperLimit': '9.4'}]}]}, {'title': 'IL-5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000', 'lowerLimit': '2.7', 'upperLimit': '2.7'}]}]}, {'title': 'IL-6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '1.6'}]}]}, {'title': 'IL-6r', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '25000', 'groupId': 'OG000', 'lowerLimit': '24000', 'upperLimit': '30000'}]}]}, {'title': 'IL-7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.2', 'groupId': 'OG000', 'lowerLimit': '8.2', 'upperLimit': '8.2'}]}]}, {'title': 'IL-8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.5', 'groupId': 'OG000', 'lowerLimit': '2.6', 'upperLimit': '4.4'}]}]}, {'title': 'IP-10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '145', 'groupId': 'OG000', 'lowerLimit': '105', 'upperLimit': '214'}]}]}, {'title': 'MCP-1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000', 'lowerLimit': '35', 'upperLimit': '67'}]}]}, {'title': 'MCP-2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000', 'lowerLimit': '15', 'upperLimit': '26'}]}]}, {'title': 'MCP-4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1640', 'groupId': 'OG000', 'lowerLimit': '1350', 'upperLimit': '1720'}]}]}, {'title': 'MIG', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'MIP-1 alpha', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000', 'lowerLimit': '18', 'upperLimit': '18'}]}]}, {'title': 'MIP-1 beta', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '193', 'groupId': 'OG000', 'lowerLimit': '175', 'upperLimit': '211'}]}]}, {'title': 'MIP-3 alpha', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000', 'lowerLimit': '15', 'upperLimit': '25'}]}]}, {'title': 'MPIF-1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '890', 'groupId': 'OG000', 'lowerLimit': '840', 'upperLimit': '1100'}]}]}, {'title': 'TNF-alpha', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000', 'lowerLimit': '13', 'upperLimit': '13'}]}]}, {'title': 'TNF-beta', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Post-dose 3 at Day 180 plus 6 Hours', 'description': 'Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.The analysis was performed only on theEngerix-B\\_2 Group.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to 30 days post last vaccination (step 2 only), which included all evaluable subjects, who complied with the protocol, and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point.'}, {'type': 'PRIMARY', 'title': 'Plasma Concentrations of Cytokines and Chemokines in Step 2 of Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Engerix-B_2 Group', 'description': 'Subjects received, during Step 2 of the study, 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}], 'classes': [{'title': 'E-selectin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4900', 'groupId': 'OG000', 'lowerLimit': '4300', 'upperLimit': '5900'}]}]}, {'title': 'GM-CSF', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000', 'lowerLimit': '14', 'upperLimit': '14'}]}]}, {'title': 'IFN-γ', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '1.6'}]}]}, {'title': 'IL-10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000', 'lowerLimit': '3.3', 'upperLimit': '3.8'}]}]}, {'title': 'IL-18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '152', 'groupId': 'OG000', 'lowerLimit': '140.5', 'upperLimit': '192'}]}]}, {'title': 'IL-2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000', 'lowerLimit': '5.9', 'upperLimit': '5.9'}]}]}, {'title': 'IL-3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '1.6'}]}]}, {'title': 'IL-4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.4', 'groupId': 'OG000', 'lowerLimit': '9.4', 'upperLimit': '11.2'}]}]}, {'title': 'IL-5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000', 'lowerLimit': '2.7', 'upperLimit': '2.7'}]}]}, {'title': 'IL-6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '1.6'}]}]}, {'title': 'IL-6r', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '24500', 'groupId': 'OG000', 'lowerLimit': '22500', 'upperLimit': '31500'}]}]}, {'title': 'IL-7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.2', 'groupId': 'OG000', 'lowerLimit': '8.2', 'upperLimit': '8.2'}]}]}, {'title': 'IL-8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.5', 'groupId': 'OG000', 'lowerLimit': '2.6', 'upperLimit': '3.5'}]}]}, {'title': 'IP-10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '152', 'groupId': 'OG000', 'lowerLimit': '119.5', 'upperLimit': '211.5'}]}]}, {'title': 'MCP-1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000', 'lowerLimit': '35', 'upperLimit': '86.5'}]}]}, {'title': 'MCP-2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '19.5', 'groupId': 'OG000', 'lowerLimit': '13', 'upperLimit': '25.5'}]}]}, {'title': 'MCP-4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1720', 'groupId': 'OG000', 'lowerLimit': '1390', 'upperLimit': '1790'}]}]}, {'title': 'MIG', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'MIP-1 alpha', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000', 'lowerLimit': '18', 'upperLimit': '18'}]}]}, {'title': 'MIP-1 beta', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '173.5', 'groupId': 'OG000', 'lowerLimit': '166.5', 'upperLimit': '213'}]}]}, {'title': 'MIP-3 alpha', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000', 'lowerLimit': '15', 'upperLimit': '21'}]}]}, {'title': 'MPIF-1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '875', 'groupId': 'OG000', 'lowerLimit': '745', 'upperLimit': '1100'}]}]}, {'title': 'TNF-alpha', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000', 'lowerLimit': '13', 'upperLimit': '13'}]}]}, {'title': 'TNF-beta', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Post-dose 3 at Day 181', 'description': 'Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma. The analysis was performed only on the Engerix-B\\_2 Group.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to 30 days post last vaccination (step 2 only), which included all evaluable subjects, who complied with the protocol, and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point.'}, {'type': 'PRIMARY', 'title': 'Plasma Concentrations of Cytokines and Chemokines During Step 2 of Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Engerix-B_2 Group', 'description': 'Subjects received, during Step 2 of the study, 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}], 'classes': [{'title': 'E-selectin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4600', 'groupId': 'OG000', 'lowerLimit': '4200', 'upperLimit': '5500'}]}]}, {'title': 'GM-CSF', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000', 'lowerLimit': '14', 'upperLimit': '14'}]}]}, {'title': 'IFN-γ', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '1.6'}]}]}, {'title': 'IL-10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000', 'lowerLimit': '3.3', 'upperLimit': '3.3'}]}]}, {'title': 'IL-18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '163', 'groupId': 'OG000', 'lowerLimit': '137', 'upperLimit': '167'}]}]}, {'title': 'IL-2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000', 'lowerLimit': '5.9', 'upperLimit': '5.9'}]}]}, {'title': 'IL-3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '1.6'}]}]}, {'title': 'IL-4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.4', 'groupId': 'OG000', 'lowerLimit': '9.4', 'upperLimit': '9.4'}]}]}, {'title': 'IL-5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000', 'lowerLimit': '2.7', 'upperLimit': '2.7'}]}]}, {'title': 'IL-6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '1.6'}]}]}, {'title': 'IL-6r', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '30000', 'groupId': 'OG000', 'lowerLimit': '26000', 'upperLimit': '35000'}]}]}, {'title': 'IL-7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.2', 'groupId': 'OG000', 'lowerLimit': '8.2', 'upperLimit': '8.2'}]}]}, {'title': 'IL-8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.5', 'groupId': 'OG000', 'lowerLimit': '3.5', 'upperLimit': '4.4'}]}]}, {'title': 'IP-10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '201', 'groupId': 'OG000', 'lowerLimit': '107', 'upperLimit': '201'}]}]}, {'title': 'MCP-1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000', 'lowerLimit': '35', 'upperLimit': '35'}]}]}, {'title': 'MCP-2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000', 'lowerLimit': '17', 'upperLimit': '25'}]}]}, {'title': 'MCP-4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1810', 'groupId': 'OG000', 'lowerLimit': '1720', 'upperLimit': '2120'}]}]}, {'title': 'MIG', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'MIP-1 alpha', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000', 'lowerLimit': '18', 'upperLimit': '18'}]}]}, {'title': 'MIP-1 beta', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '175', 'groupId': 'OG000', 'lowerLimit': '175', 'upperLimit': '193'}]}]}, {'title': 'MIP-3 alpha', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000', 'lowerLimit': '17', 'upperLimit': '25'}]}]}, {'title': 'MPIF-1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '820', 'groupId': 'OG000', 'lowerLimit': '750', 'upperLimit': '970'}]}]}, {'title': 'TNF-alpha', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000', 'lowerLimit': '13', 'upperLimit': '13'}]}]}, {'title': 'TNF-beta', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Post-dose 3 at Day 187', 'description': 'Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma. The analysis was performed only on the Engerix-B\\_2 Group.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).'}, {'type': 'SECONDARY', 'title': 'Anti-Hepatitis B Surface (Anti-HBs) Antibody Concentrations in Serum - Step 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HBsAg/AS_1 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}, {'id': 'OG001', 'title': 'Engerix-B_1 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}], 'classes': [{'title': 'Anti-HBs, PRE (D0)', 'categories': [{'measurements': [{'value': '3.1', 'groupId': 'OG000', 'lowerLimit': '3.1', 'upperLimit': '3.1'}, {'value': '3.1', 'groupId': 'OG001', 'lowerLimit': '3.1', 'upperLimit': '3.1'}]}]}, {'title': 'Anti-HBs, PII (D60)', 'categories': [{'measurements': [{'value': '3322.4', 'groupId': 'OG000', 'lowerLimit': '2332.2', 'upperLimit': '4733.0'}, {'value': '35.8', 'groupId': 'OG001', 'lowerLimit': '11.6', 'upperLimit': '111.1'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Day 0 (PRE) and Day 60 (D60) post-vaccination', 'description': 'Anti-HBs antibody concentrations in serum were measured by Chemi Luminiscence Immuno Assay (CLIA). Concentrations were presented as geometric mean concentrations, in milli-International Units per milliliter (mIU/mL).', 'unitOfMeasure': 'mIU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for adaptive immunogenicity up to Day 60 (step 1 only) which included all evaluable subjects who complied with the protocol and for whom data concerning adaptive immunogenicity were available for at least one adaptive assay at one post-vaccination time point (up to Day 60).'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HBsAg/AS_1 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}, {'id': 'OG001', 'title': 'Engerix-B_1 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}], 'classes': [{'title': 'Any pain, PP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 pain, PP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Any redness, PP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 redness, PP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any swelling, PP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 swelling, PP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any pain, D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 pain, D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any redness, D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 redness, D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any swelling, D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 swelling, D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any pain, D2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 pain, D2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Any redness, D2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 redness, D2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any swelling, D2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 swelling, D2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any pain, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 pain, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Any redness, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 redness, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any swelling, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 swelling, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 7-day (Days 0-6) post-placebo (PP) and post-vaccination period following each vaccine dose (D1 and D2) and across doses', 'description': 'Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented, who have filled in their symptom sheets.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HBsAg/AS_1 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}, {'id': 'OG001', 'title': 'Engerix-B_1 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}], 'classes': [{'title': 'Any fatigue, PP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 fatigue, PP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Related fatigue, PP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Any gastrointestinal symptoms, PP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 gastrointestinal symptoms, PP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Related gastrointestinal symptoms, PP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any headache, PP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 headache, PP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Related headache, PP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Any malaise, PP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 malaise, PP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related malaise, PP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Any myalgia, PP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 myalgia, PP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Related myalgia, PP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any shivering, PP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 shivering, PP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Related shivering, PP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any temperature, PP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 temperature, PP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related temperature, PP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Fatigue, D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 fatigue, D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related fatigue, D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Any gastrointestinal symptoms, D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 gastrointestinal symptoms, D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Related gastrointestinal symptoms, D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Any headache, D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 headache, D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Related headache, D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Any malaise, D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 malaise, D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related malaise, D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Any myalgia, D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 myalgia, D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related myalgia, D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Any shivering, D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 shivering, D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related shivering, D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any temperature (≥37.5 °C), D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 temperature (> 39.5 °C), D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related temperature, D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Fatigue, D2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 fatigue, D2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related fatigue, D2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Any gastrointestinal symptoms, D2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 gastrointestinal symptoms, D2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Related gastrointestinal symptoms, D2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Any headache, D2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 headache, D2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Related headache, D2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Any malaise, D2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 malaise, D2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Related malaise, D2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Any myalgia, D2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 myalgia, D2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related myalgia, D2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Any shivering, D2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 shivering, D2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related shivering, D2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Any temperature (≥37.5 °C), D2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 temperature (> 39.5 °C), D2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related temperature, D2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Fatigue, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 fatigue, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related fatigue, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Any gastrointestinal symptoms, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 gastrointestinal symptoms, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Related gastrointestinal symptoms, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Any headache, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 headache, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Related headache, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Any malaise, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 malaise, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Related malaise, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Any myalgia, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 myalgia, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related myalgia, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Any shivering, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 shivering, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related shivering, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Any temperature (≥37.5 °C), Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 temperature (> 39.5 °C), Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related temperature, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 7-day (Days 0-6) post-placebo (PP) and post-vaccination period following each vaccine dose (D1 and D2) and across doses', 'description': 'Assessed solicited general symptoms were fatigue, gastrointestinal symptoms \\[nausea, vomiting, diarrhoea and /or abdominal pain\\], headache, malaise, myalgia, shivering and temperature \\[defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)\\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \\> 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented, who have filled in their symptom sheets.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HBsAg/AS_1 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}, {'id': 'OG001', 'title': 'Engerix-B_1 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}], 'classes': [{'title': 'Fever (≥37.5), placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Fever (≥37.5), D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Fever (≥37.5), D2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Pain, placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Pain, D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Pain, D2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Redness, placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Redness, D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Redness, D2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Induration, placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Induration, D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Induration, D2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Swelling, placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Swelling, D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Swelling, D2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Muscle stiffness, placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Muscle stiffness, D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Muscle stiffness, D2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 4 days post-placebo/vaccine administration.', 'description': 'Assessed solicited symptoms were fever \\[defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)\\], pain, redness \\[spreading beyond 20 millimeters (mm) of injection site\\], induration \\[spreading beyond 20 millimeters (mm) of injection site\\], swelling \\[spreading beyond 20 millimeters (mm) of injection site\\] and muscle stiffness.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Any Unsolicited Adverse Events (AEs) - Step 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HBsAg/AS_1 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}, {'id': 'OG001', 'title': 'Engerix-B_1 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}], 'classes': [{'title': 'Any AEs, post-placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'Any AEs, post-product administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within the 28-day (Days 0-27) post-placebo (PP) and post-product administration period.', 'description': 'An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset out-side the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Serious Adverse Events (SAEs) - Step 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HBsAg/AS_1 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}, {'id': 'OG001', 'title': 'Engerix-B_1 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}], 'classes': [{'title': 'Day 60 SAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 210 SAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Day 0 up to Day 60 for the HBsAg/AS_1 Group and from Day 0 up to Day 210 for the Engerix-B_1 Group', 'description': 'Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Any Potential Immune-mediated Disorders (pIMDs) - Step 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HBsAg/AS_1 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}, {'id': 'OG001', 'title': 'Engerix-B_1 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}], 'classes': [{'title': 'pIMDs - Day 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'pIMDs - Day 210', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Day 0 up to Day 60 for the HBsAg/AS_1 Group and from Day 0 up to Day 210 for the Engerix-B_1 Group', 'description': 'PIMD(s) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Any New Medical Conditions Requiring Medical Attention (MAEs) - Step 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HBsAg/AS_1 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}, {'id': 'OG001', 'title': 'Engerix-B_1 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}], 'classes': [{'title': 'MAEs - Day 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'MAEs - Day 210', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Day 0 up to Day 60 for the HBsAg/AS_1 Group and from Day 0 up to Day 210 for the Engerix-B_1 Group', 'description': 'MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination. Analysis of intensity and relationship to vaccination of MAEs was not performed.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.'}, {'type': 'SECONDARY', 'title': 'Levels of Alanine Aminotransferase (ALT) in Blood Samples - Step 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HBsAg/AS_1 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}, {'id': 'OG001', 'title': 'Engerix-B_1 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}], 'classes': [{'title': 'ALT, Dose 1, Day 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '27.5', 'groupId': 'OG000', 'lowerLimit': '22.5', 'upperLimit': '32.5'}, {'value': '27', 'groupId': 'OG001', 'lowerLimit': '23', 'upperLimit': '31'}]}]}, {'title': 'ALT, Dose 1 (Day 0 H6)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '26.5', 'groupId': 'OG000', 'lowerLimit': '22', 'upperLimit': '33'}, {'value': '26', 'groupId': 'OG001', 'lowerLimit': '22', 'upperLimit': '34'}]}]}, {'title': 'ALT, Dose 1 (Day 0 H12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000', 'lowerLimit': '23.5', 'upperLimit': '31.5'}, {'value': '26', 'groupId': 'OG001', 'lowerLimit': '24', 'upperLimit': '33'}]}]}, {'title': 'ALT, Dose 1 (Day 0 H18)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000', 'lowerLimit': '25', 'upperLimit': '35'}, {'value': '24', 'groupId': 'OG001', 'lowerLimit': '16', 'upperLimit': '48'}]}]}, {'title': 'ALT, Dose 1, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25.5', 'groupId': 'OG000', 'lowerLimit': '20', 'upperLimit': '33'}, {'value': '27', 'groupId': 'OG001', 'lowerLimit': '20', 'upperLimit': '35'}]}]}, {'title': 'ALT, Dose 1, Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '26.5', 'groupId': 'OG000', 'lowerLimit': '22', 'upperLimit': '32.5'}, {'value': '28', 'groupId': 'OG001', 'lowerLimit': '19', 'upperLimit': '34'}]}]}, {'title': 'ALT, Dose 2, Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000', 'lowerLimit': '22', 'upperLimit': '36'}, {'value': '30', 'groupId': 'OG001', 'lowerLimit': '24', 'upperLimit': '33'}]}]}, {'title': 'ALT, Dose 2 (Day 30 H6)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000', 'lowerLimit': '23', 'upperLimit': '34'}, {'value': '28', 'groupId': 'OG001', 'lowerLimit': '25', 'upperLimit': '32'}]}]}, {'title': 'ALT, Dose 2 (Day 30 H12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000', 'lowerLimit': '24', 'upperLimit': '34'}, {'value': '28', 'groupId': 'OG001', 'lowerLimit': '23', 'upperLimit': '33.5'}]}]}, {'title': 'ALT, Dose 2 (Day 30 H18)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000', 'lowerLimit': '25', 'upperLimit': '37'}, {'value': '26', 'groupId': 'OG001', 'lowerLimit': '24', 'upperLimit': '46'}]}]}, {'title': 'ALT, Dose 2, Day 31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000', 'lowerLimit': '22', 'upperLimit': '33'}, {'value': '27', 'groupId': 'OG001', 'lowerLimit': '23', 'upperLimit': '34'}]}]}, {'title': 'ALT, Dose 2, Day 37', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000', 'lowerLimit': '22', 'upperLimit': '30'}, {'value': '26', 'groupId': 'OG001', 'lowerLimit': '23.5', 'upperLimit': '33'}]}]}, {'title': 'ALT, Dose 2, Day 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000', 'lowerLimit': '23', 'upperLimit': '32'}, {'value': '28', 'groupId': 'OG001', 'lowerLimit': '22.5', 'upperLimit': '36'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At Day 0, Day 0 H6, Day 0 H12, Day 0 H18, Day 1, Day 7, Day 30, Day 30 H6, Day 30 H12, Day 30 H18, Day 31, Day 37 and Day 60', 'description': 'Biochemical laboratory parameters assessed included ALT levels. ALT concentrations were expressed in units per liter (U/L). ALT levels were assessed at different time points (plus 6, 12 and 18 hours - H6, H12, H18) on Day 0 and Day 30.', 'unitOfMeasure': 'U/L', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.'}, {'type': 'SECONDARY', 'title': 'Levels of Aspartate Aminotransferase (AST) in Blood Samples - Step 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HBsAg/AS_1 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. 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AST concentrations were expressed in units per liter (U/L). AST levels were assessed at different time points (plus 6, 12 and 18 hours - H6, H12, H18) on Day 0 and Day 30.', 'unitOfMeasure': 'U/L', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.'}, {'type': 'SECONDARY', 'title': 'Levels of Basophils in Blood Samples - Step 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HBsAg/AS_1 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}, {'id': 'OG001', 'title': 'Engerix-B_1 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}], 'classes': [{'title': 'Basophils, Dose 1, Day 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.03', 'groupId': 'OG000', 'lowerLimit': '0.02', 'upperLimit': '0.04'}, {'value': '0.02', 'groupId': 'OG001', 'lowerLimit': '0.02', 'upperLimit': '0.03'}]}]}, {'title': 'Basophils, Dose 1 (Day 0 H6)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.03', 'groupId': 'OG000', 'lowerLimit': '0.02', 'upperLimit': '0.04'}, {'value': '0.03', 'groupId': 'OG001', 'lowerLimit': '0.02', 'upperLimit': '0.03'}]}]}, {'title': 'Basophils, Dose 1 (Day 0 H12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.03', 'groupId': 'OG000', 'lowerLimit': '0.02', 'upperLimit': '0.05'}, {'value': '0.02', 'groupId': 'OG001', 'lowerLimit': '0.02', 'upperLimit': '0.03'}]}]}, {'title': 'Basophils, Dose 1 (Day 0 H18)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.03', 'groupId': 'OG000', 'lowerLimit': '0.01', 'upperLimit': '0.03'}, {'value': '0.02', 'groupId': 'OG001', 'lowerLimit': '0.01', 'upperLimit': '0.03'}]}]}, {'title': 'Basophils, Dose 1, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.03', 'groupId': 'OG000', 'lowerLimit': '0.01', 'upperLimit': '0.04'}, {'value': '0.02', 'groupId': 'OG001', 'lowerLimit': '0.02', 'upperLimit': '0.03'}]}]}, {'title': 'Basophils, Dose 1, Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.03', 'groupId': 'OG000', 'lowerLimit': '0.02', 'upperLimit': '0.04'}, {'value': '0.03', 'groupId': 'OG001', 'lowerLimit': '0.02', 'upperLimit': '0.04'}]}]}, {'title': 'Basophils, Dose 2, Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.03', 'groupId': 'OG000', 'lowerLimit': '0.02', 'upperLimit': '0.04'}, {'value': '0.02', 'groupId': 'OG001', 'lowerLimit': '0.02', 'upperLimit': '0.04'}]}]}, {'title': 'Basophils, Dose 2 (Day 30 H6)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.03', 'groupId': 'OG000', 'lowerLimit': '0.02', 'upperLimit': '0.04'}, {'value': '0.02', 'groupId': 'OG001', 'lowerLimit': '0.02', 'upperLimit': '0.03'}]}]}, {'title': 'Basophils, Dose 2 (Day 30 H12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.02', 'groupId': 'OG000', 'lowerLimit': '0.01', 'upperLimit': '0.03'}, {'value': '0.02', 'groupId': 'OG001', 'lowerLimit': '0.02', 'upperLimit': '0.04'}]}]}, {'title': 'Basophils, Dose 2 (Day 30 H18)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.03', 'groupId': 'OG000', 'lowerLimit': '0.01', 'upperLimit': '0.03'}, {'value': '0.02', 'groupId': 'OG001', 'lowerLimit': '0.01', 'upperLimit': '0.03'}]}]}, {'title': 'Basophils, Dose 2, Day 31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.02', 'groupId': 'OG000', 'lowerLimit': '0.01', 'upperLimit': '0.03'}, {'value': '0.03', 'groupId': 'OG001', 'lowerLimit': '0.02', 'upperLimit': '0.04'}]}]}, {'title': 'Basophils, Dose 2, Day 37', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.03', 'groupId': 'OG000', 'lowerLimit': '0.02', 'upperLimit': '0.06'}, {'value': '0.03', 'groupId': 'OG001', 'lowerLimit': '0.02', 'upperLimit': '0.03'}]}]}, {'title': 'Basophils, Dose 2, Day 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.03', 'groupId': 'OG000', 'lowerLimit': '0.02', 'upperLimit': '0.04'}, {'value': '0.03', 'groupId': 'OG001', 'lowerLimit': '0.02', 'upperLimit': '0.03'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At Day 0, Day 0 H6, Day 0 H12, Day 0 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Basophil levels were expressed in billion cells per liter (billion cells/L). Basophil levels were assessed at different time points (plus 6, 12 and 18 hours - H6, H12, H18) on Day 0 and Day 30.', 'unitOfMeasure': 'billion cells/L', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.'}, {'type': 'SECONDARY', 'title': 'Levels of Total Bilirubin in Blood Samples - Step 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HBsAg/AS_1 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}, {'id': 'OG001', 'title': 'Engerix-B_1 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}], 'classes': [{'title': 'Total bilirubin, Dose 1, Day 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000', 'lowerLimit': '0.4', 'upperLimit': '0.7'}, {'value': '0.5', 'groupId': 'OG001', 'lowerLimit': '0.3', 'upperLimit': '0.7'}]}]}, {'title': 'Total bilirubin, Dose 1 (Day 0 H6)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000', 'lowerLimit': '0.25', 'upperLimit': '0.5'}, {'value': '0.4', 'groupId': 'OG001', 'lowerLimit': '0.3', 'upperLimit': '0.5'}]}]}, {'title': 'Total bilirubin, Dose 1 (Day 0 H12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': 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[{'value': '28', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.9', 'groupId': 'OG000', 'lowerLimit': '0.5', 'upperLimit': '4.25'}, {'value': '1.3', 'groupId': 'OG001', 'lowerLimit': '0.5', 'upperLimit': '2.6'}]}]}, {'title': 'CRP, Dose 2, Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000', 'lowerLimit': '0.5', 'upperLimit': '4.3'}, {'value': '1.4', 'groupId': 'OG001', 'lowerLimit': '0.5', 'upperLimit': '3.1'}]}]}, {'title': 'CRP, Dose 2 (Day 30 H6)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.2', 'groupId': 'OG000', 'lowerLimit': '0.5', 'upperLimit': '2.3'}, {'value': '1.5', 'groupId': 'OG001', 'lowerLimit': '0.5', 'upperLimit': '3.05'}]}]}, {'title': 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CRP concentrations were expressed in milligrams per liter (mg/L). CRP levels were assessed at different time points (plus 6, 12 and 18 hours - H6, H12, H18) on Day 0 and Day 30.', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.'}, {'type': 'SECONDARY', 'title': 'Levels of Eosinophils in Blood Samples - Step 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HBsAg/AS_1 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. 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Eosinophil levels were expressed in billion cells per liter (billion cells/L). Eosinophil levels were assessed at different time points (plus 6, 12 and 18 hours - H6, H12, H18) on Day 0 and Day 30.', 'unitOfMeasure': 'billion cells/L', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.'}, {'type': 'SECONDARY', 'title': 'Levels of Haemoglobin in Blood Samples - Step 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HBsAg/AS_1 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. 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{'title': 'LDH, Dose 2 (Day 30 H12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '425', 'groupId': 'OG000', 'lowerLimit': '403', 'upperLimit': '470'}, {'value': '382.5', 'groupId': 'OG001', 'lowerLimit': '338.5', 'upperLimit': '424'}]}]}, {'title': 'LDH, Dose 2 (Day 30 H18)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '403', 'groupId': 'OG000', 'lowerLimit': '365', 'upperLimit': '450'}, {'value': '334.5', 'groupId': 'OG001', 'lowerLimit': '297', 'upperLimit': '390'}]}]}, {'title': 'LDH, Dose 2, Day 31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '408', 'groupId': 'OG000', 'lowerLimit': '373', 'upperLimit': '453'}, {'value': '372', 'groupId': 'OG001', 'lowerLimit': '354', 'upperLimit': '403'}]}]}, {'title': 'LDH, Dose 2, Day 37', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '442', 'groupId': 'OG000', 'lowerLimit': '412', 'upperLimit': '464'}, {'value': '403', 'groupId': 'OG001', 'lowerLimit': '368.5', 'upperLimit': '446'}]}]}, {'title': 'LDH, Dose 2, Day 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '422', 'groupId': 'OG000', 'lowerLimit': '397', 'upperLimit': '478'}, {'value': '404', 'groupId': 'OG001', 'lowerLimit': '374', 'upperLimit': '431.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At Day 0, Day 0 H6, Day 0 H12, Day 0 H18, Day 1, Day 7, Day 30, Day 30 H6, Day 30 H12, Day 30 H18, Day 31, Day 37 and Day 60', 'description': 'Biochemical 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LDH levels were assessed at different time points (plus 6, 12 and 18 hours - H6, H12, H18) on Day 0 and Day 30.', 'unitOfMeasure': 'U/L', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.'}, {'type': 'SECONDARY', 'title': 'Levels of Lymphocytes in Blood Samples - Step 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HBsAg/AS_1 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. 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'lowerLimit': '6.78', 'upperLimit': '9.36'}, {'value': '6.34', 'groupId': 'OG001', 'lowerLimit': '5.67', 'upperLimit': '7.16'}]}]}, {'title': 'WBC, Dose 2, Day 37', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.7', 'groupId': 'OG000', 'lowerLimit': '5.13', 'upperLimit': '8.46'}, {'value': '6.25', 'groupId': 'OG001', 'lowerLimit': '5.46', 'upperLimit': '7.31'}]}]}, {'title': 'WBC, Dose 2, Day 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.48', 'groupId': 'OG000', 'lowerLimit': '5.45', 'upperLimit': '8.24'}, {'value': '6.07', 'groupId': 'OG001', 'lowerLimit': '5.04', 'upperLimit': '6.7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At Day 0, Day 0 H6, Day 0 H12, Day 0 H18, Day 1, Day 7, Day 30, Day 30 H6, Day 30 H12, Day 30 H18, Day 31, Day 37 and Day 60', 'description': 'Haematological laboratory parameters assessed included WBC levels. WBC levels were expressed in billion cells per liter (billion cells/L). WBC levels were assessed at different time points (plus 6, 12 and 18 hours - H6, H12, H18) on Day 0 and Day 30.', 'unitOfMeasure': 'billion cells/L', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.'}, {'type': 'SECONDARY', 'title': 'Levels of Diastolic Blood Pressure - Step 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HBsAg/AS_1 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}, {'id': 'OG001', 'title': 'Engerix-B_1 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}], 'classes': [{'title': 'Diastolic, placebo (D-30)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '81', 'groupId': 'OG000', 'lowerLimit': '74', 'upperLimit': '86'}, {'value': '76.5', 'groupId': 'OG001', 'lowerLimit': '67', 'upperLimit': '83'}]}]}, {'title': 'Diastolic, placebo (D-30 H1.5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000', 'lowerLimit': '69', 'upperLimit': '83'}, {'value': '72', 'groupId': 'OG001', 'lowerLimit': '65', 'upperLimit': '79'}]}]}, {'title': 'Diastolic, placebo (D-30 H3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '75.5', 'groupId': 'OG000', 'lowerLimit': '68', 'upperLimit': '83'}, {'value': '71.5', 'groupId': 'OG001', 'lowerLimit': '65', 'upperLimit': '80'}]}]}, {'title': 'Diastolic, placebo (D-30 H6)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '73.5', 'groupId': 'OG000', 'lowerLimit': '67', 'upperLimit': '83'}, {'value': '71.5', 'groupId': 'OG001', 'lowerLimit': '67', 'upperLimit': '82'}]}]}, {'title': 'Diastolic, placebo (D-30 H9)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000', 'lowerLimit': '71', 'upperLimit': '86'}, {'value': '75', 'groupId': 'OG001', 'lowerLimit': '67', 'upperLimit': '84'}]}]}, {'title': 'Diastolic, placebo (D-30 H12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '78', 'groupId': 'OG000', 'lowerLimit': '69', 'upperLimit': '84'}, {'value': '72.5', 'groupId': 'OG001', 'lowerLimit': '66', 'upperLimit': '80'}]}]}, {'title': 'Diastolic, placebo (D-30 H18)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000', 'lowerLimit': '67', 'upperLimit': '80'}, {'value': '68', 'groupId': 'OG001', 'lowerLimit': '64', 'upperLimit': '84'}]}]}, {'title': 'Diastolic, placebo (D-29)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '77', 'groupId': 'OG000', 'lowerLimit': '70', 'upperLimit': '83'}, {'value': '73.5', 'groupId': 'OG001', 'lowerLimit': '64', 'upperLimit': '81'}]}]}, {'title': 'Diastolic, placebo (D-28)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000', 'lowerLimit': '70', 'upperLimit': '83'}, {'value': '74.5', 'groupId': 'OG001', 'lowerLimit': '69', 'upperLimit': '78'}]}]}, {'title': 'Diastolic, placebo (D-27)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '78', 'groupId': 'OG000', 'lowerLimit': '72', 'upperLimit': '82'}, {'value': '75', 'groupId': 'OG001', 'lowerLimit': '71', 'upperLimit': '81'}]}]}, {'title': 'Diastolic, placebo (D-23)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000', 'lowerLimit': '71', 'upperLimit': '81'}, {'value': '75.5', 'groupId': 'OG001', 'lowerLimit': '66', 'upperLimit': '80'}]}]}, {'title': 'Diastolic, Dose 1 (D0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000', 'lowerLimit': '70.5', 'upperLimit': '83'}, {'value': '76', 'groupId': 'OG001', 'lowerLimit': '68', 'upperLimit': '85'}]}]}, {'title': 'Diastolic, Dose 1 (D0 H1.5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000', 'lowerLimit': '70', 'upperLimit': '81'}, {'value': '73', 'groupId': 'OG001', 'lowerLimit': '67', 'upperLimit': '78'}]}]}, {'title': 'Diastolic, Dose 1 (D0 H6)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '73.5', 'groupId': 'OG000', 'lowerLimit': '67.5', 'upperLimit': '80'}, {'value': '72', 'groupId': 'OG001', 'lowerLimit': '65', 'upperLimit': '78'}]}]}, {'title': 'Diastolic, Dose 1 (D0 H12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000', 'lowerLimit': '69', 'upperLimit': '79.5'}, {'value': '72', 'groupId': 'OG001', 'lowerLimit': '66', 'upperLimit': '79'}]}]}, {'title': 'Diastolic, Dose 1 (D0 H18)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000', 'lowerLimit': '61', 'upperLimit': '78'}, {'value': '66.5', 'groupId': 'OG001', 'lowerLimit': '60', 'upperLimit': '78'}]}]}, {'title': 'Diastolic, Dose 1 (D1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000', 'lowerLimit': '69', 'upperLimit': '79'}, {'value': '76', 'groupId': 'OG001', 'lowerLimit': '66', 'upperLimit': '80'}]}]}, {'title': 'Diastolic, Dose 1 (D2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000', 'lowerLimit': '70', 'upperLimit': '81.5'}, {'value': '73', 'groupId': 'OG001', 'lowerLimit': '67', 'upperLimit': '79'}]}]}, {'title': 'Diastolic, Dose 1 (D7)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000', 'lowerLimit': '71', 'upperLimit': '79.5'}, {'value': '73', 'groupId': 'OG001', 'lowerLimit': '70', 'upperLimit': '82'}]}]}, {'title': 'Diastolic, Dose 2 (D30)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000', 'lowerLimit': '69', 'upperLimit': '80'}, {'value': '77.5', 'groupId': 'OG001', 'lowerLimit': '68.5', 'upperLimit': '83'}]}]}, {'title': 'Diastolic, Dose 2 (D30 H1.5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000', 'lowerLimit': '67', 'upperLimit': '78'}, {'value': '70', 'groupId': 'OG001', 'lowerLimit': '66', 'upperLimit': '76.5'}]}]}, {'title': 'Diastolic, Dose 2 (D30 H3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000', 'lowerLimit': '68', 'upperLimit': '79'}, {'value': '72', 'groupId': 'OG001', 'lowerLimit': '63', 'upperLimit': '78'}]}]}, {'title': 'Diastolic, Dose 2 (D30 H6)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000', 'lowerLimit': '69', 'upperLimit': '75'}, {'value': '70.5', 'groupId': 'OG001', 'lowerLimit': '65.5', 'upperLimit': '75.5'}]}]}, {'title': 'Diastolic, Dose 2 (D30 H9)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000', 'lowerLimit': '71', 'upperLimit': '79'}, {'value': '75', 'groupId': 'OG001', 'lowerLimit': '65.5', 'upperLimit': '81.5'}]}]}, {'title': 'Diastolic, Dose 2 (D30 H12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000', 'lowerLimit': '68', 'upperLimit': '78'}, {'value': '72.5', 'groupId': 'OG001', 'lowerLimit': '66.5', 'upperLimit': '79.5'}]}]}, {'title': 'Diastolic, Dose 2 (D30 H18)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000', 'lowerLimit': '64', 'upperLimit': '74'}, {'value': '71.5', 'groupId': 'OG001', 'lowerLimit': '66', 'upperLimit': '79'}]}]}, {'title': 'Diastolic, Dose 2 (D31)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '71', 'groupId': 'OG000', 'lowerLimit': '67', 'upperLimit': '77'}, {'value': '71', 'groupId': 'OG001', 'lowerLimit': '65.5', 'upperLimit': '80'}]}]}, {'title': 'Diastolic, Dose 2 (D32)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '77', 'groupId': 'OG000', 'lowerLimit': '71', 'upperLimit': '81'}, {'value': '74', 'groupId': 'OG001', 'lowerLimit': '67', 'upperLimit': '79'}]}]}, {'title': 'Diastolic, Dose 2 (D33)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '77', 'groupId': 'OG000', 'lowerLimit': '71', 'upperLimit': '81'}, {'value': '73', 'groupId': 'OG001', 'lowerLimit': '70.5', 'upperLimit': '79.5'}]}]}, {'title': 'Diastolic, Dose 2 (D37)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000', 'lowerLimit': '68', 'upperLimit': '86'}, {'value': '74', 'groupId': 'OG001', 'lowerLimit': '68.5', 'upperLimit': '79.5'}]}]}, {'title': 'Diastolic, Dose 2 (D60)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '78', 'groupId': 'OG000', 'lowerLimit': '72', 'upperLimit': '84'}, {'value': '73', 'groupId': 'OG001', 'lowerLimit': '67', 'upperLimit': '81.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At Day -30, -30 (H1.5, H3, H6, H9, H12, H18) -29, - 28, - 27, -23, 0, 0 (H1.5, H6, H12 H18), 1, 2, 7, 30, 30 (H1.5, H3, H6, H9, H12, H18), 31, 32, 33, 37 and 60', 'description': 'Diastolic pressure was part of the list of vital signs followed at specific protocol-defined time points during this study, measured in millimeter of mercury (mmHg). On Days -30, 0 and 30, diastolic blood pressure was assessed at multiple time points (plus 1.5, 3, 6, 9, 12 and 18 hours - H1.5, H3, H6, H9, H12 and H18).', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.'}, {'type': 'SECONDARY', 'title': 'Levels of Heart Rate - Step 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HBsAg/AS_1 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}, {'id': 'OG001', 'title': 'Engerix-B_1 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}], 'classes': [{'title': 'Heart rate, placebo (D-30)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '75.5', 'groupId': 'OG000', 'lowerLimit': '62', 'upperLimit': '86'}, {'value': '70', 'groupId': 'OG001', 'lowerLimit': '64', 'upperLimit': '79'}]}]}, {'title': 'Heart rate, placebo (D-30 H1.5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000', 'lowerLimit': '62', 'upperLimit': '82'}, {'value': '73', 'groupId': 'OG001', 'lowerLimit': '62', 'upperLimit': '77'}]}]}, {'title': 'Heart rate, placebo (D-30 H3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '69.5', 'groupId': 'OG000', 'lowerLimit': '56', 'upperLimit': '76'}, {'value': '63.5', 'groupId': 'OG001', 'lowerLimit': '58', 'upperLimit': '71'}]}]}, {'title': 'Heart rate, placebo (D-30 H6)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000', 'lowerLimit': '61', 'upperLimit': '78'}, {'value': '69', 'groupId': 'OG001', 'lowerLimit': '60', 'upperLimit': '80'}]}]}, {'title': 'Heart rate, placebo (D-30 H9)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '66.5', 'groupId': 'OG000', 'lowerLimit': '56', 'upperLimit': '82'}, {'value': '65', 'groupId': 'OG001', 'lowerLimit': '55', 'upperLimit': '70'}]}]}, {'title': 'Heart rate, placebo (D-30 H12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '71.5', 'groupId': 'OG000', 'lowerLimit': '64', 'upperLimit': '80'}, {'value': '72.5', 'groupId': 'OG001', 'lowerLimit': '60', 'upperLimit': '81'}]}]}, {'title': 'Heart rate, placebo (D-30 H18)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000', 'lowerLimit': '55', 'upperLimit': '75'}, {'value': '70', 'groupId': 'OG001', 'lowerLimit': '66', 'upperLimit': '77'}]}]}, {'title': 'Heart rate, placebo (D-29)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '74.5', 'groupId': 'OG000', 'lowerLimit': '63', 'upperLimit': '82'}, {'value': '65.5', 'groupId': 'OG001', 'lowerLimit': '62', 'upperLimit': '70'}]}]}, {'title': 'Heart rate, placebo (D-28)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000', 'lowerLimit': '66', 'upperLimit': '82'}, {'value': '73.5', 'groupId': 'OG001', 'lowerLimit': '65', 'upperLimit': '81'}]}]}, {'title': 'Heart rate, placebo (D-27)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000', 'lowerLimit': '66', 'upperLimit': '80'}, {'value': '70', 'groupId': 'OG001', 'lowerLimit': '65', 'upperLimit': '81'}]}]}, {'title': 'Heart rate, placebo (D-23)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000', 'lowerLimit': '66', 'upperLimit': '80'}, {'value': '66', 'groupId': 'OG001', 'lowerLimit': '58', 'upperLimit': '75'}]}]}, {'title': 'Heart rate, Dose 1 (D0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '69.5', 'groupId': 'OG000', 'lowerLimit': '62', 'upperLimit': '80.5'}, {'value': '72', 'groupId': 'OG001', 'lowerLimit': '62', 'upperLimit': '79'}]}]}, {'title': 'Heart rate, Dose 1 (D0 H1.5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '67.5', 'groupId': 'OG000', 'lowerLimit': '62', 'upperLimit': '76'}, {'value': '68', 'groupId': 'OG001', 'lowerLimit': '62', 'upperLimit': '77'}]}]}, {'title': 'Heart rate, Dose 1 (D0 H6)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000', 'lowerLimit': '60.5', 'upperLimit': '80.5'}, {'value': '68', 'groupId': 'OG001', 'lowerLimit': '65', 'upperLimit': '79'}]}]}, {'title': 'Heart rate, Dose 1 (D0 H12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000', 'lowerLimit': '66.5', 'upperLimit': '83'}, {'value': '69', 'groupId': 'OG001', 'lowerLimit': '61', 'upperLimit': '79'}]}]}, {'title': 'Heart rate, Dose 1 (D0 H18)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000', 'lowerLimit': '60', 'upperLimit': '83'}, {'value': '67', 'groupId': 'OG001', 'lowerLimit': '60', 'upperLimit': '77'}]}]}, {'title': 'Heart rate, Dose 1 (D1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000', 'lowerLimit': '65', 'upperLimit': '82'}, {'value': '67', 'groupId': 'OG001', 'lowerLimit': '64', 'upperLimit': '75'}]}]}, {'title': 'Heart rate, Dose 1 (D2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '71.5', 'groupId': 'OG000', 'lowerLimit': '60', 'upperLimit': '80'}, {'value': '69', 'groupId': 'OG001', 'lowerLimit': '65', 'upperLimit': '79'}]}]}, {'title': 'Heart rate, Dose 1 (D7)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000', 'lowerLimit': '63', 'upperLimit': '80.5'}, {'value': '71', 'groupId': 'OG001', 'lowerLimit': '62', 'upperLimit': '82'}]}]}, {'title': 'Heart rate, Dose 2 (D30)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000', 'lowerLimit': '59', 'upperLimit': '77'}, {'value': '66.5', 'groupId': 'OG001', 'lowerLimit': '58', 'upperLimit': '76.5'}]}]}, {'title': 'Heart rate, Dose 2 (D30 H1.5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000', 'lowerLimit': '60', 'upperLimit': '78'}, {'value': '68.5', 'groupId': 'OG001', 'lowerLimit': '57.5', 'upperLimit': '79'}]}]}, {'title': 'Heart rate, Dose 2 (D30 H3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000', 'lowerLimit': '55', 'upperLimit': '74'}, {'value': '65', 'groupId': 'OG001', 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'OG001'}]}], 'categories': [{'measurements': [{'value': '117.5', 'groupId': 'OG000', 'lowerLimit': '112', 'upperLimit': '126'}, {'value': '114', 'groupId': 'OG001', 'lowerLimit': '105', 'upperLimit': '118'}]}]}, {'title': 'Systolic, placebo (D-30 H6)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '118', 'groupId': 'OG000', 'lowerLimit': '113', 'upperLimit': '124'}, {'value': '112', 'groupId': 'OG001', 'lowerLimit': '105', 'upperLimit': '124'}]}]}, {'title': 'Systolic, placebo (D-30 H9)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '120.5', 'groupId': 'OG000', 'lowerLimit': '112', 'upperLimit': '131'}, {'value': '114.5', 'groupId': 'OG001', 'lowerLimit': '106', 'upperLimit': '123'}]}]}, {'title': 'Systolic, placebo (D-30 H12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '121.5', 'groupId': 'OG000', 'lowerLimit': '112', 'upperLimit': '129'}, {'value': '112', 'groupId': 'OG001', 'lowerLimit': '105', 'upperLimit': '125'}]}]}, {'title': 'Systolic, placebo (D-30 H18)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '111', 'groupId': 'OG000', 'lowerLimit': '106', 'upperLimit': '122'}, {'value': '106', 'groupId': 'OG001', 'lowerLimit': '96', 'upperLimit': '118'}]}]}, {'title': 'Systolic, placebo (D-29)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '116.5', 'groupId': 'OG000', 'lowerLimit': '111', 'upperLimit': '124'}, {'value': '112', 'groupId': 'OG001', 'lowerLimit': '104', 'upperLimit': '122'}]}]}, {'title': 'Systolic, placebo (D-28)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '121', 'groupId': 'OG000', 'lowerLimit': '110', 'upperLimit': '124'}, {'value': '114', 'groupId': 'OG001', 'lowerLimit': '103', 'upperLimit': '121'}]}]}, {'title': 'Systolic, placebo (D-27)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '119', 'groupId': 'OG000', 'lowerLimit': '112', 'upperLimit': '124'}, {'value': '115.5', 'groupId': 'OG001', 'lowerLimit': '109', 'upperLimit': '121'}]}]}, {'title': 'Systolic, placebo (D-23)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '118', 'groupId': 'OG000', 'lowerLimit': '110', 'upperLimit': '123'}, {'value': '115', 'groupId': 'OG001', 'lowerLimit': '104', 'upperLimit': '122'}]}]}, {'title': 'Systolic, Dose 1 (D0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '118', 'groupId': 'OG000', 'lowerLimit': '112', 'upperLimit': '122.5'}, {'value': '114', 'groupId': 'OG001', 'lowerLimit': '108', 'upperLimit': '124'}]}]}, {'title': 'Systolic, Dose 1 (D0 H1.5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '116', 'groupId': 'OG000', 'lowerLimit': '110.5', 'upperLimit': '121.5'}, {'value': '109', 'groupId': 'OG001', 'lowerLimit': '102', 'upperLimit': '119'}]}]}, {'title': 'Systolic, Dose 1 (D0 H6)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '117', 'groupId': 'OG000', 'lowerLimit': '111', 'upperLimit': '121.5'}, {'value': '112', 'groupId': 'OG001', 'lowerLimit': '103', 'upperLimit': '117'}]}]}, {'title': 'Systolic, Dose 1 (D0 H12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '115', 'groupId': 'OG000', 'lowerLimit': '110', 'upperLimit': '126'}, {'value': '114', 'groupId': 'OG001', 'lowerLimit': '107', 'upperLimit': '120'}]}]}, {'title': 'Systolic, Dose 1 (D0 H18)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '112', 'groupId': 'OG000', 'lowerLimit': '104', 'upperLimit': '121'}, {'value': '105', 'groupId': 'OG001', 'lowerLimit': '99', 'upperLimit': '122'}]}]}, {'title': 'Systolic, Dose 1 (D1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '114', 'groupId': 'OG000', 'lowerLimit': '108.5', 'upperLimit': '119'}, {'value': '114', 'groupId': 'OG001', 'lowerLimit': '104', 'upperLimit': '123'}]}]}, {'title': 'Systolic, Dose 1 (D2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '115', 'groupId': 'OG000', 'lowerLimit': '110', 'upperLimit': '124'}, {'value': '111', 'groupId': 'OG001', 'lowerLimit': '103', 'upperLimit': '118'}]}]}, {'title': 'Systolic, Dose 1 (D7)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '116', 'groupId': 'OG000', 'lowerLimit': '111', 'upperLimit': '120.5'}, {'value': '113', 'groupId': 'OG001', 'lowerLimit': '107', 'upperLimit': '123'}]}]}, {'title': 'Systolic, Dose 2 (D30)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '115', 'groupId': 'OG000', 'lowerLimit': '112', 'upperLimit': '121'}, {'value': '112.5', 'groupId': 'OG001', 'lowerLimit': '106.5', 'upperLimit': '122.5'}]}]}, {'title': 'Systolic, Dose 2 (D30 H1.5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '115', 'groupId': 'OG000', 'lowerLimit': '108', 'upperLimit': '124'}, {'value': '109.5', 'groupId': 'OG001', 'lowerLimit': '102', 'upperLimit': '117.5'}]}]}, {'title': 'Systolic, Dose 2 (D30 H3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '116', 'groupId': 'OG000', 'lowerLimit': '111', 'upperLimit': '124'}, {'value': '113', 'groupId': 'OG001', 'lowerLimit': '103', 'upperLimit': '120.5'}]}]}, {'title': 'Systolic, Dose 2 (D30 H6)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '117', 'groupId': 'OG000', 'lowerLimit': '107', 'upperLimit': '122'}, {'value': '112', 'groupId': 'OG001', 'lowerLimit': '103.5', 'upperLimit': '118'}]}]}, {'title': 'Systolic, Dose 2 (D30 H9)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '117', 'groupId': 'OG000', 'lowerLimit': '108', 'upperLimit': '121'}, {'value': '116', 'groupId': 'OG001', 'lowerLimit': '108.5', 'upperLimit': '124'}]}]}, {'title': 'Systolic, Dose 2 (D30 H12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '116', 'groupId': 'OG000', 'lowerLimit': '109', 'upperLimit': '125'}, {'value': '116.5', 'groupId': 'OG001', 'lowerLimit': '105', 'upperLimit': '122'}]}]}, {'title': 'Systolic, Dose 2 (D30 H18)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '109.5', 'groupId': 'OG000', 'lowerLimit': '102', 'upperLimit': '115'}, {'value': '107', 'groupId': 'OG001', 'lowerLimit': '100', 'upperLimit': '122'}]}]}, {'title': 'Systolic, Dose 2 (D31)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '114', 'groupId': 'OG000', 'lowerLimit': '108', 'upperLimit': '123'}, {'value': '109.5', 'groupId': 'OG001', 'lowerLimit': '104', 'upperLimit': '119'}]}]}, {'title': 'Systolic, Dose 2 (D32)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '116', 'groupId': 'OG000', 'lowerLimit': '113', 'upperLimit': '120'}, {'value': '110.5', 'groupId': 'OG001', 'lowerLimit': '103', 'upperLimit': '115.5'}]}]}, {'title': 'Systolic, Dose 2 (D33)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '116', 'groupId': 'OG000', 'lowerLimit': '112', 'upperLimit': '122'}, {'value': '111.5', 'groupId': 'OG001', 'lowerLimit': '106', 'upperLimit': '119.5'}]}]}, {'title': 'Systolic, Dose 2 (D37)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '120', 'groupId': 'OG000', 'lowerLimit': '108', 'upperLimit': '126'}, {'value': '112', 'groupId': 'OG001', 'lowerLimit': '106', 'upperLimit': '124.5'}]}]}, {'title': 'Systolic, Dose 2 (D60)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '120', 'groupId': 'OG000', 'lowerLimit': '109', 'upperLimit': '125'}, {'value': '115', 'groupId': 'OG001', 'lowerLimit': '106.5', 'upperLimit': '122.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At Day -30, -30 (H1.5, H3, H6, H9, H12, H18) -29, - 28, - 27, -23, 0, 0 (H1.5, H6, H12 H18), 1, 2, 7, 30, 30 (H1.5, H3, H6, H9, H12, H18), 31, 32, 33, 37 and 60', 'description': 'Systolic pressure was part of the list of vital signs followed at specific protocol-defined time points during this study, measured in millimeter of mercury (mmHg). On Days -30, 0 and 30, systolic pressure was assessed at multiple time points (plus 1.5, 3, 6, 9, 12 and 18 hours - H1.5, H3, H6, H9, H12 and H18).', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.'}, {'type': 'SECONDARY', 'title': 'Anti-Hepatitis B Surface (Anti-HBs) Antibody Concentrations in Serum - Step 2 Immuno', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HBsAg/AS_2 Group', 'description': 'Subjects received, during Step 2 of the study, 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm'}, {'id': 'OG001', 'title': 'Engerix-B_2 Group', 'description': 'Subjects received, during Step 2 of the study, 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}], 'classes': [{'title': 'Anti-HBs, PRE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.1', 'groupId': 'OG000', 'lowerLimit': '3.1', 'upperLimit': '3.1'}, {'value': '3.1', 'groupId': 'OG001', 'lowerLimit': '3.1', 'upperLimit': '3.1'}]}]}, {'title': 'Anti-HBs, D44', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8447.1', 'groupId': 'OG000', 'lowerLimit': '4040.7', 'upperLimit': '17658.9'}]}]}, {'title': 'Anti-HBs, D194', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1996.3', 'groupId': 'OG001', 'lowerLimit': '143.8', 'upperLimit': '27707.6'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Day 0 (PRE) and post-vaccination (Day 44 for HBsAg/AS_2 Group and Day 194 for Engerix-B_2 Group)', 'description': 'Anti-HBs antibody concentrations in serum were measured by CLIA Assay. Concentrations were presented as geometric mean concentrations, in milli-International Units per milliliter (mIU/mL).', 'unitOfMeasure': 'mIU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyses were performed on the According-To-Protocol (ATP) cohort for adaptive immunogenicity up to 30 days (step 2 only) post last vaccination, which included all evaluable subjects, who complied with the protocol and for whom data concerning adaptive immunogenicity were available for at least one adaptive assay at one post-vaccination time point.'}, {'type': 'SECONDARY', 'title': 'Anti-Hepatitis B Surface (Anti-HBs) Antibody Concentrations in Serum - Step 2 Persistence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HBsAg/AS_2 Group', 'description': 'Subjects received, during Step 2 of the study, 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm'}, {'id': 'OG001', 'title': 'Engerix-B_2 Group', 'description': 'Subjects received, during Step 2 of the study, 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}], 'classes': [{'title': 'Anti-HBs, PRE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.1', 'groupId': 'OG000', 'lowerLimit': '3.1', 'upperLimit': '3.1'}, {'value': '3.1', 'groupId': 'OG001', 'lowerLimit': '3.1', 'upperLimit': '3.1'}]}]}, {'title': 'Anti-HBs, D44', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8447.1', 'groupId': 'OG000', 'lowerLimit': '4040.7', 'upperLimit': '17658.9'}]}]}, {'title': 'Anti-HBs, D194', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2454.9', 'groupId': 'OG001', 'lowerLimit': '311.4', 'upperLimit': '19354.5'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Day 0 (PRE) and post-vaccination (Day 44 for HBsAg/AS_2 Group and Day 194 for Engerix-B_2 Group)', 'description': 'Anti-HBs antibody concentrations in serum were measured by CLIA Assay. Concentrations were presented as geometric mean concentrations, in milli-International Units per milliliter (mIU/mL).', 'unitOfMeasure': 'mIU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol (ATP) cohort for persistence (step 2 only) included all evaluable subjects, who complied with the protocol, for whom data concerning adaptive immunogenicity were available for at least one adaptive assay at Day 180 for the HBsAg/AS\\_2 Group and at Day 330 for the Engerix-B\\_2 Group.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HBsAg/AS_2 Group', 'description': 'Subjects received, during Step 2 of the study, 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm'}, {'id': 'OG001', 'title': 'Engerix-B_2 Group', 'description': 'Subjects received, during Step 2 of the study, 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}], 'classes': [{'title': 'Any Pain, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Pain, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Redness, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Redness, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Swelling, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Swelling, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Pain, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Pain, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Redness, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Redness, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Swelling, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Swelling, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Pain, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Pain, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Redness, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Redness, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Swelling, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Swelling, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Pain, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Pain, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Redness, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Redness, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Swelling, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Swelling, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 7-day (Days 0-6) post-vaccination period following each vaccine dose and across doses', 'description': 'Assessed solicited local symptoms were pain, redness and swelling. 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'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Any Shivering, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Shivering, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related Shivering, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 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'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related Headache, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Malaise, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Malaise, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related Malaise, Dose 2', 'denoms': [{'units': 'Participants', 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'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Temperature, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related Temperature, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Fatigue, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Fatigue, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related Fatigue, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Any Gastrointestinal Symptoms, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Gastrointestinal Symptoms, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related Gastrointestinal Symptoms, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Any Headache, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Headache, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related Headache, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Any Malaise, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Malaise, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related Malaise, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Myalgia, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Myalgia, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related Myalgia, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Shivering, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Shivering, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related Shivering, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Temperature, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Temperature, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related Temperature, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Fatigue, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Fatigue, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related Fatigue, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Any Gastrointestinal Symptoms, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Gastrointestinal Symptoms, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related Gastrointestinal Symptoms, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Any Headache, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Headache, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related Headache, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Any Malaise, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Malaise, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related Malaise, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Myalgia, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Myalgia, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related Myalgia, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Any Shivering, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Shivering, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related Shivering, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Any Temperature, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Temperature, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related Temperature, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 7-day (Days 0-6) post-vaccination period following each vaccine dose and across doses', 'description': 'Assessed solicited general symptoms were fatigue, gastrointestinal symptoms \\[nausea, vomiting, diarrhoea and/or abdominal pain\\], headache, malaise, myalgia, shivering and temperature \\[defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)\\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \\> 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination. At Day 0 of dose 2, two temperatures were collected: one at Hour 0 (H0) and a second one at Hour 18 (H18). The highest temperature between H0 et H18 was taken.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HBsAg/AS_1+2 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30; or during Step 2 of the study, 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}, {'id': 'OG001', 'title': 'Engerix-B_1+2 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180; or during Step 2 of the study, 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}], 'classes': [{'title': 'Any Fatigue, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Fatigue, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related Fatigue, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Any Gastrointestinal Symptoms, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Gastrointestinal Symptoms, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Related Gastrointestinal Symptoms, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Any Headache, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Headache, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Related Headache, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Any Malaise, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Malaise, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related Malaise, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Any Myalgia, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Myalgia, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related Myalgia, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Any Shivering, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Shivering, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related Shivering, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Any Fatigue, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Fatigue, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related Fatigue, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Any Gastrointestinal Symptoms, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Gastrointestinal Symptoms, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Related Gastrointestinal Symptoms, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Any Headache, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Headache, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Related Headache, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Any Malaise, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Malaise, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Related Malaise, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Any Myalgia, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Myalgia, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related Myalgia, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Any Shivering, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Shivering, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related Shivering, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Any Fatigue, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Fatigue, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related Fatigue, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Any Gastrointestinal Symptoms, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Gastrointestinal Symptoms, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related Gastrointestinal Symptoms, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Any Headache, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Headache, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related Headache, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Any Malaise, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Malaise, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related Malaise, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Myalgia, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Myalgia, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related Myalgia, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Shivering, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Shivering, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related Shivering, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Fatigue, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Fatigue, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related Fatigue, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Any Gastrointestinal Symptoms, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Gastrointestinal Symptoms, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Related Gastrointestinal Symptoms, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Any Headache, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Headache, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Related Headache, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Any Malaise, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Malaise, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Related Malaise, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Any Myalgia, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Myalgia, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related Myalgia, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Any Shivering, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Shivering, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related Shivering, Across doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 7-day (Days 0-6) post-vaccination period following each vaccine dose and across doses', 'description': 'Assessed solicited general symptoms were fatigue, gastrointestinal symptoms \\[nausea, vomiting, diarrhoea and/or abdominal pain\\], headache, malaise, myalgia, shivering and temperature \\[defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)\\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \\> 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination. There was no pooling for temperature symptom between Step 1 and Step 2 due to difference in recording approach for the 18 hour data (nurse or self-assessment).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Any Unsolicited Adverse Events (AEs) - Step 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HBsAg/AS_2 Group', 'description': 'Subjects received, during Step 2 of the study, 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm'}, {'id': 'OG001', 'title': 'Engerix-B_2 Group', 'description': 'Subjects received, during Step 2 of the study, 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within the 28-day (Days 0-27) and post-vaccination period', 'description': 'An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset out-side the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Any Unsolicited Adverse Events (AEs) - Pooling Step', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HBsAg/AS_1+2 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30; or during Step 2 of the study, 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}, {'id': 'OG001', 'title': 'Engerix-B_1+2 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180; or during Step 2 of the study, 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within the 28-day (Days 0-27) post-vaccination period.', 'description': 'An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset out-side the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Serious Adverse Events (SAEs) - Step 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HBsAg/AS_2 Group', 'description': 'Subjects received, during Step 2 of the study, 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm'}, {'id': 'OG001', 'title': 'Engerix-B_2 Group', 'description': 'Subjects received, during Step 2 of the study, 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Day 180 for the HBsAg/AS_2 Group and up to Day 330 for the Engerix-B_2 Group', 'description': 'Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Serious Adverse Events (SAEs) - Pooling Step', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HBsAg/AS_1+2 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30; or during Step 2 of the study, 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}, {'id': 'OG001', 'title': 'Engerix-B_1+2 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180; or during Step 2 of the study, 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Day 180 for the HBsAg/AS_1+2 Group and up to Day 330 for the Engerix-B_1+2 Group', 'description': 'Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Any Potential Immune-mediated Disorders (pIMDs) - Step 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HBsAg/AS_2 Group', 'description': 'Subjects received, during Step 2 of the study, 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm'}, {'id': 'OG001', 'title': 'Engerix-B_2 Group', 'description': 'Subjects received, during Step 2 of the study, 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Day 180 for the HBsAg/AS_2 Group and up to Day 330 for the Engerix-B_2 Group', 'description': 'PIMD(s) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Any Potential Immune-mediated Disorders (pIMDs) - Pooling Step', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HBsAg/AS_1+2 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30; or during Step 2 of the study, 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}, {'id': 'OG001', 'title': 'Engerix-B_1+2 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180; or during Step 2 of the study, 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Day 180 for the HBsAg/AS_1+2 Group and up to Day 330 for the Engerix-B_1+2 Group', 'description': 'PIMD(s) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Any New Medical Conditions Requiring Medical Attention (MAEs) - Step 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HBsAg/AS_2 Group', 'description': 'Subjects received, during Step 2 of the study, 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm'}, {'id': 'OG001', 'title': 'Engerix-B_2 Group', 'description': 'Subjects received, during Step 2 of the study, 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Day 180 for the HBsAg/AS_2 Group and up to Day 330 for the Engerix-B_2 Group', 'description': 'MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Any New Medical Conditions Requiring Medical Attention (MAEs) - Pooling Step', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HBsAg/AS_1+2 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30; or during Step 2 of the study, 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}, {'id': 'OG001', 'title': 'Engerix-B_1+2 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180; or during Step 2 of the study, 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Day 180 for the HBsAg/AS_1+2 Group and up to Day 330 for the Engerix-B_1+2 Group', 'description': 'MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.'}, {'type': 'SECONDARY', 'title': 'Levels of Alanine Aminotransferase (ALT) in Blood Samples - Step 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HBsAg/AS_2 Group', 'description': 'Subjects received, during Step 2 of the study, 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm'}, {'id': 'OG001', 'title': 'Engerix-B_2 Group', 'description': 'Subjects received, during Step 2 of the study, 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}], 'classes': [{'title': 'ALT, PRE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '27.5', 'groupId': 'OG000', 'lowerLimit': '23', 'upperLimit': '33'}, {'value': '31', 'groupId': 'OG001', 'lowerLimit': '28', 'upperLimit': '38'}]}]}, {'title': 'ALT, D30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25.5', 'groupId': 'OG000', 'lowerLimit': '25', 'upperLimit': '31'}]}]}, {'title': 'ALT, D32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000', 'lowerLimit': '20', 'upperLimit': '36'}]}]}, {'title': 'ALT, D37', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000', 'lowerLimit': '18', 'upperLimit': '31'}]}]}, {'title': 'ALT, D60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000', 'lowerLimit': '23', 'upperLimit': '33'}]}]}, {'title': 'ALT, D180', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '34.5', 'groupId': 'OG001', 'lowerLimit': '27', 'upperLimit': '45'}]}]}, {'title': 'ALT, D182', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG001', 'lowerLimit': '25', 'upperLimit': '42'}]}]}, {'title': 'ALT, D187', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG001', 'lowerLimit': '29', 'upperLimit': '40'}]}]}, {'title': 'ALT, D210', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29.5', 'groupId': 'OG001', 'lowerLimit': '22', 'upperLimit': '48'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At Day 0 (PRE), Day 30, Day 32, Day 37, Day 60 for the HBsAg/AS_2 Group and Day 0 (PRE) Day 180, Day 182, Day 187 and Day 210 for the Engerix-B_2 Group', 'description': 'Biochemical laboratory parameters assessed included ALT levels. ALT concentrations were expressed in units per liter (U/L).', 'unitOfMeasure': 'U/L', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.'}, {'type': 'SECONDARY', 'title': 'Levels of Aspartate Aminotransferase (AST) in Blood Samples - Step 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HBsAg/AS_2 Group', 'description': 'Subjects received, during Step 2 of the study, 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm'}, {'id': 'OG001', 'title': 'Engerix-B_2 Group', 'description': 'Subjects received, during Step 2 of the study, 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}], 'classes': [{'title': 'AST, PRE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22.5', 'groupId': 'OG000', 'lowerLimit': '21', 'upperLimit': '24'}, {'value': '28', 'groupId': 'OG001', 'lowerLimit': '23', 'upperLimit': '38'}]}]}, {'title': 'AST, D30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22.5', 'groupId': 'OG000', 'lowerLimit': '20', 'upperLimit': '26'}]}]}, {'title': 'AST, D32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000', 'lowerLimit': '22', 'upperLimit': '26'}]}]}, {'title': 'AST, D37', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20.5', 'groupId': 'OG000', 'lowerLimit': '18', 'upperLimit': '24'}]}]}, {'title': 'AST, D60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21.5', 'groupId': 'OG000', 'lowerLimit': '18', 'upperLimit': '31'}]}]}, {'title': 'AST, D180', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG001', 'lowerLimit': '18', 'upperLimit': '43'}]}]}, {'title': 'AST, D182', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG001', 'lowerLimit': '23', 'upperLimit': '39'}]}]}, {'title': 'AST, D187', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG001', 'lowerLimit': '20', 'upperLimit': '36'}]}]}, {'title': 'AST, D210', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22.5', 'groupId': 'OG001', 'lowerLimit': '20', 'upperLimit': '28'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At Day 0 (PRE), Day 30, Day 32, Day 37, Day 60 for the HBsAg/AS_2 Group and Day 0 (PRE) Day 180, Day 182, Day 187 and Day 210 for the Engerix-B_2 Group', 'description': 'Biochemical laboratory parameters assessed included AST levels. AST concentrations were expressed in units per liter (U/L).', 'unitOfMeasure': 'U/L', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.'}, {'type': 'SECONDARY', 'title': 'Levels of Basophils in Blood Samples - Step 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HBsAg/AS_2 Group', 'description': 'Subjects received, during Step 2 of the study, 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm'}, {'id': 'OG001', 'title': 'Engerix-B_2 Group', 'description': 'Subjects received, during Step 2 of the study, 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}], 'classes': [{'title': 'Basophils, PRE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.04', 'groupId': 'OG000', 'lowerLimit': '0.02', 'upperLimit': '0.05'}, {'value': '0.03', 'groupId': 'OG001', 'lowerLimit': '0.02', 'upperLimit': '0.04'}]}]}, {'title': 'Basophils, D30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.02', 'groupId': 'OG000', 'lowerLimit': '0.01', 'upperLimit': '0.07'}]}]}, {'title': 'Basophils, D32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.04', 'groupId': 'OG000', 'lowerLimit': '0.02', 'upperLimit': '0.05'}]}]}, {'title': 'Basophils, D37', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.03', 'groupId': 'OG000', 'lowerLimit': '0.01', 'upperLimit': '0.06'}]}]}, {'title': 'Basophils, D60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.05', 'groupId': 'OG000', 'lowerLimit': '0.02', 'upperLimit': '0.06'}]}]}, {'title': 'Basophils, D180', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.02', 'groupId': 'OG001', 'lowerLimit': '0.01', 'upperLimit': '0.04'}]}]}, {'title': 'Basophils, D182', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.02', 'groupId': 'OG001', 'lowerLimit': '0.01', 'upperLimit': '0.04'}]}]}, {'title': 'Basophils, D187', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.03', 'groupId': 'OG001', 'lowerLimit': '0.02', 'upperLimit': '0.05'}]}]}, {'title': 'Basophils, D210', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.03', 'groupId': 'OG001', 'lowerLimit': '0.01', 'upperLimit': '0.04'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At Day 0 (PRE), Day 30, Day 32, Day 37, Day 60 for the HBsAg/AS_2 Group and Day 0 (PRE) Day 180, Day 182, Day 187 and Day 210 for the Engerix-B_2 Group', 'description': 'Haematological laboratory parameters assessed included basophil levels. Basophil levels were expressed in billion cells per liter (billion cells/L).', 'unitOfMeasure': 'billion cells/L', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.'}, {'type': 'SECONDARY', 'title': 'Levels of Serum C Reactive Protein (CRP) in Blood Samples - Step 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HBsAg/AS_2 Group', 'description': 'Subjects received, during Step 2 of the study, 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm'}, {'id': 'OG001', 'title': 'Engerix-B_2 Group', 'description': 'Subjects received, during Step 2 of the study, 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}], 'classes': [{'title': 'CRP, PRE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.55', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '6.8'}, {'value': '5.8', 'groupId': 'OG001', 'lowerLimit': '5', 'upperLimit': '9.5'}]}]}, {'title': 'CRP, D2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '24.2', 'groupId': 'OG000', 'lowerLimit': '16.6', 'upperLimit': '32.7'}, {'value': '5', 'groupId': 'OG001', 'lowerLimit': '5', 'upperLimit': '8.8'}]}]}, {'title': 'CRP, D30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.8', 'groupId': 'OG000', 'lowerLimit': '5.1', 'upperLimit': '8.2'}]}]}, {'title': 'CRP, D31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20.45', 'groupId': 'OG000', 'lowerLimit': '10.4', 'upperLimit': '21.9'}]}]}, {'title': 'CRP, D32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '33.75', 'groupId': 'OG000', 'lowerLimit': '12.7', 'upperLimit': '44.6'}]}]}, {'title': 'CRP, D37', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.7', 'groupId': 'OG000', 'lowerLimit': '5.5', 'upperLimit': '10'}]}]}, {'title': 'CRP, D60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '6.2'}]}]}, {'title': 'CRP, D180', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.25', 'groupId': 'OG001', 'lowerLimit': '5', 'upperLimit': '6.8'}]}]}, {'title': 'CRP, D181', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG001', 'lowerLimit': '5', 'upperLimit': '6'}]}]}, {'title': 'CRP, D182', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG001', 'lowerLimit': '5', 'upperLimit': '7.3'}]}]}, {'title': 'CRP, D187', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG001', 'lowerLimit': '5', 'upperLimit': '6.7'}]}]}, {'title': 'CRP, D210', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG001', 'lowerLimit': '5', 'upperLimit': '7.8'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At Day 0 (PRE), Day 30, Day 32, Day 37, Day 60 for the HBsAg/AS_2 Group and Day 0 (PRE) Day 180, Day 182, Day 187 and Day 210 for the Engerix-B_2 Group', 'description': 'Biochemical laboratory parameters assessed included CRP levels. CRP concentrations were expressed in milligrams per liter (mg/L).', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.'}, {'type': 'SECONDARY', 'title': 'Levels of Eosinophils in Blood Samples - Step 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HBsAg/AS_2 Group', 'description': 'Subjects received, during Step 2 of the study, 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm'}, {'id': 'OG001', 'title': 'Engerix-B_2 Group', 'description': 'Subjects received, during Step 2 of the study, 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}], 'classes': [{'title': 'Eosinophils, PRE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.16', 'groupId': 'OG000', 'lowerLimit': '0.09', 'upperLimit': '0.23'}, {'value': '0.18', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '0.29'}]}]}, {'title': 'Eosinophils, D30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.17', 'groupId': 'OG000', 'lowerLimit': '0.12', 'upperLimit': '0.23'}]}]}, {'title': 'Eosinophils, D32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.25', 'groupId': 'OG000', 'lowerLimit': '0.17', 'upperLimit': '0.33'}]}]}, {'title': 'Eosinophils, D37', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.19', 'groupId': 'OG000', 'lowerLimit': '0.11', 'upperLimit': '0.26'}]}]}, {'title': 'Eosinophils, D60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000', 'lowerLimit': '0.09', 'upperLimit': '0.26'}]}]}, {'title': 'Eosinophils, D180', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.14', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '0.2'}]}]}, {'title': 'Eosinophils, D182', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.17', 'groupId': 'OG001', 'lowerLimit': '0.11', 'upperLimit': '0.19'}]}]}, {'title': 'Eosinophils, D187', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.18', 'groupId': 'OG001', 'lowerLimit': '0.16', 'upperLimit': '0.27'}]}]}, {'title': 'Eosinophils, D210', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.16', 'groupId': 'OG001', 'lowerLimit': '0.09', 'upperLimit': '0.26'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At Day 0 (PRE), Day 30, Day 32, Day 37, Day 60 for the HBsAg/AS_2 Group and Day 0 (PRE) Day 180, Day 182, Day 187 and Day 210 for the Engerix-B_2 Group', 'description': 'Haematological laboratory parameters assessed included eosinophil levels. Eosinophil levels were expressed in billion cells per liter (billion cells/L).', 'unitOfMeasure': 'billion cells/L', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.'}, {'type': 'SECONDARY', 'title': 'Levels of White Blood Cell (WBC) in Blood Samples - Step 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HBsAg/AS_2 Group', 'description': 'Subjects received, during Step 2 of the study, 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm'}, {'id': 'OG001', 'title': 'Engerix-B_2 Group', 'description': 'Subjects received, during Step 2 of the study, 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. 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Lymphocyte levels were expressed in billion cells per liter (billion cells/L).', 'unitOfMeasure': 'billion cells/L', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.'}, {'type': 'SECONDARY', 'title': 'Levels of Monocytes in Blood Samples - Step 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HBsAg/AS_2 Group', 'description': 'Subjects received, during Step 2 of the study, 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm'}, {'id': 'OG001', 'title': 'Engerix-B_2 Group', 'description': 'Subjects received, during Step 2 of the study, 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}], 'classes': [{'title': 'Monocytes, D0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.64', 'groupId': 'OG000', 'lowerLimit': '0.47', 'upperLimit': '0.74'}, {'value': '0.5', 'groupId': 'OG001', 'lowerLimit': '0.28', 'upperLimit': '0.69'}]}]}, {'title': 'Monocytes, D30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.54', 'groupId': 'OG000', 'lowerLimit': '0.38', 'upperLimit': '0.62'}]}]}, {'title': 'Monocytes, D32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.87', 'groupId': 'OG000', 'lowerLimit': '0.8', 'upperLimit': '1.07'}]}]}, {'title': 'Monocytes, D37', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.47', 'groupId': 'OG000', 'lowerLimit': '0.43', 'upperLimit': '0.58'}]}]}, {'title': 'Monocytes, D60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.58', 'groupId': 'OG000', 'lowerLimit': '0.49', 'upperLimit': '0.68'}]}]}, {'title': 'Monocytes, D180', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.46', 'groupId': 'OG001', 'lowerLimit': '0.39', 'upperLimit': '0.57'}]}]}, {'title': 'Monocytes, D182', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.43', 'groupId': 'OG001', 'lowerLimit': '0.42', 'upperLimit': '0.66'}]}]}, {'title': 'Monocytes, D187', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.44', 'groupId': 'OG001', 'lowerLimit': '0.37', 'upperLimit': '0.55'}]}]}, {'title': 'Monocytes, D210', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.52', 'groupId': 'OG001', 'lowerLimit': '0.34', 'upperLimit': '0.62'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At Day 0 (PRE), Day 30, Day 32, Day 37, Day 60 for the HBsAg/AS_2 Group and Day 0 (PRE) Day 180, Day 182, Day 187 and Day 210 for the Engerix-B_2 Group', 'description': 'Haematological laboratory parameters assessed included monocyte levels. Monocyte levels were expressed in billion cells per liter (billion cells/L).', 'unitOfMeasure': 'billion cells/L', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.'}, {'type': 'SECONDARY', 'title': 'Levels of Neutrophils in Blood Samples - Step 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HBsAg/AS_2 Group', 'description': 'Subjects received, during Step 2 of the study, 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm'}, {'id': 'OG001', 'title': 'Engerix-B_2 Group', 'description': 'Subjects received, during Step 2 of the study, 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}], 'classes': [{'title': 'Neutrophils, D0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.02', 'groupId': 'OG000', 'lowerLimit': '3.12', 'upperLimit': '6.22'}, {'value': '3.11', 'groupId': 'OG001', 'lowerLimit': '2.3', 'upperLimit': '4.56'}]}]}, {'title': 'Neutrophils, D30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.41', 'groupId': 'OG000', 'lowerLimit': '2.87', 'upperLimit': '3.93'}]}]}, {'title': 'Neutrophils, D32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.42', 'groupId': 'OG000', 'lowerLimit': '2.78', 'upperLimit': '5.01'}]}]}, {'title': 'Neutrophils, D37', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.22', 'groupId': 'OG000', 'lowerLimit': '2.76', 'upperLimit': '3.9'}]}]}, {'title': 'Neutrophils, D60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.18', 'groupId': 'OG000', 'lowerLimit': '2.96', 'upperLimit': '5.34'}]}]}, {'title': 'Neutrophils, D180', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.29', 'groupId': 'OG001', 'lowerLimit': '2.99', 'upperLimit': '4.67'}]}]}, {'title': 'Neutrophils, D182', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.16', 'groupId': 'OG001', 'lowerLimit': '2.89', 'upperLimit': '4.88'}]}]}, {'title': 'Neutrophils, D187', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.9', 'groupId': 'OG001', 'lowerLimit': '3.18', 'upperLimit': '4.29'}]}]}, {'title': 'Neutrophils, D210', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.28', 'groupId': 'OG001', 'lowerLimit': '2.29', 'upperLimit': '4.88'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At Day 0 (PRE), Day 30, Day 32, Day 37, Day 60 for the HBsAg/AS_2 Group and Day 0 (PRE) Day 180, Day 182, Day 187 and Day 210 for the Engerix-B_2 Group', 'description': 'Haematological laboratory parameters assessed included neutrophil levels. Neutrophil levels were expressed in billion cells per liter (billion cells/L).', 'unitOfMeasure': 'billion cells/L', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.'}, {'type': 'SECONDARY', 'title': 'Platelet Count in Blood Samples - Step 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HBsAg/AS_2 Group', 'description': 'Subjects received, during Step 2 of the study, 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm'}, {'id': 'OG001', 'title': 'Engerix-B_2 Group', 'description': 'Subjects received, during Step 2 of the study, 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}], 'classes': [{'title': 'Platelets, D0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '269', 'groupId': 'OG000', 'lowerLimit': '255', 'upperLimit': '312'}, {'value': '272', 'groupId': 'OG001', 'lowerLimit': '215', 'upperLimit': '322'}]}]}, {'title': 'Platelets, D30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '272.5', 'groupId': 'OG000', 'lowerLimit': '215', 'upperLimit': '330'}]}]}, {'title': 'Platelets, D32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '257', 'groupId': 'OG000', 'lowerLimit': '204', 'upperLimit': '303'}]}]}, {'title': 'Platelets, D37', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '315.5', 'groupId': 'OG000', 'lowerLimit': '286', 'upperLimit': '330'}]}]}, {'title': 'Platelets, D60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '282', 'groupId': 'OG000', 'lowerLimit': '257', 'upperLimit': '323'}]}]}, {'title': 'Platelets, D180', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '247', 'groupId': 'OG001', 'lowerLimit': '237', 'upperLimit': '276'}]}]}, {'title': 'Platelets, D182', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '263', 'groupId': 'OG001', 'lowerLimit': '248', 'upperLimit': '274'}]}]}, {'title': 'Platelets, D187', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '272', 'groupId': 'OG001', 'lowerLimit': '260', 'upperLimit': '280'}]}]}, {'title': 'Platelets, D210', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '264.5', 'groupId': 'OG001', 'lowerLimit': '214', 'upperLimit': '314'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At Day 0 (PRE), Day 30, Day 32, Day 37, Day 60 for the HBsAg/AS_2 Group and Day 0 (PRE) Day 180, Day 182, Day 187 and Day 210 for the Engerix-B_2 Group', 'description': 'Haematological laboratory parameters assessed included platelet count levels. Platelet count levels were expressed in billion cells per liter (billion cells/L).', 'unitOfMeasure': 'billion cells/L', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.'}, {'type': 'SECONDARY', 'title': 'Levels of Total Bilirubin in Blood Samples - Step 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HBsAg/AS_2 Group', 'description': 'Subjects received, during Step 2 of the study, 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}, {'id': 'OG001', 'title': 'Engerix-B_2 Group', 'description': 'Subjects received, during Step 2 of the study, 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}], 'classes': [{'title': 'Total Bilirubin, PRE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000', 'lowerLimit': '0.4', 'upperLimit': '0.8'}, {'value': '0.5', 'groupId': 'OG001', 'lowerLimit': '0.3', 'upperLimit': '0.7'}]}]}, {'title': 'Total Bilirubin, D2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.45', 'groupId': 'OG000', 'lowerLimit': '0.4', 'upperLimit': '0.6'}, {'value': '0.5', 'groupId': 'OG001', 'lowerLimit': '0.3', 'upperLimit': '1.5'}]}]}, {'title': 'Total Bilirubin, D30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.45', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': '0.8'}]}]}, {'title': 'Total Bilirubin, D31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.55', 'groupId': 'OG000', 'lowerLimit': '0.4', 'upperLimit': '1'}]}]}, {'title': 'Total Bilirubin, D32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '0.6'}]}]}, {'title': 'Total Bilirubin, D37', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.45', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': '0.6'}]}]}, {'title': 'Total Bilirubin, D60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': '0.6'}]}]}, {'title': 'Total Bilirubin, D180', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.45', 'groupId': 'OG001', 'lowerLimit': '0.4', 'upperLimit': '0.6'}]}]}, {'title': 'Total Bilirubin, D181', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG001', 'lowerLimit': '0.4', 'upperLimit': '0.7'}]}]}, {'title': 'Total Bilirubin, D182', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG001', 'lowerLimit': '0.5', 'upperLimit': '0.7'}]}]}, {'title': 'Total Bilirubin, D187', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG001', 'lowerLimit': '0.5', 'upperLimit': '0.7'}]}]}, {'title': 'Total Bilirubin, D210', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG001', 'lowerLimit': '0.5', 'upperLimit': '0.7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At Day 0 (PRE), Day 30, Day 32, Day 37, Day 60 for the HBsAg/AS_2 Group and Day 0 (PRE) Day 180, Day 182, Day 187 and Day 210 for the Engerix-B_2 Group', 'description': 'Biochemical laboratory parameters assessed included total bilirubin levels. Bilirubin concentrations were expressed in milligrams per deciliter (mG/dL).', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.'}, {'type': 'SECONDARY', 'title': 'Levels of Diastolic Blood Pressure - Step 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HBsAg/AS_2 Group', 'description': 'Subjects received, during Step 2 of the study, 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm'}, {'id': 'OG001', 'title': 'Engerix-B_2 Group', 'description': 'Subjects received, during Step 2 of the study, 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}], 'classes': [{'title': 'Diastolic, D0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000', 'lowerLimit': '69', 'upperLimit': '75'}, {'value': '70', 'groupId': 'OG001', 'lowerLimit': '67', 'upperLimit': '72'}]}]}, {'title': 'Diastolic, D30 H0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '74.5', 'groupId': 'OG000', 'lowerLimit': '73', 'upperLimit': '78'}]}]}, {'title': 'Diastolic, D30 H6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '71', 'groupId': 'OG000', 'lowerLimit': '69', 'upperLimit': '75'}]}]}, {'title': 'Diastolic, D31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '71.5', 'groupId': 'OG000', 'lowerLimit': '68', 'upperLimit': '78'}]}]}, {'title': 'Diastolic, D32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '71.5', 'groupId': 'OG000', 'lowerLimit': '66', 'upperLimit': '82'}]}]}, {'title': 'Diastolic, D37', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000', 'lowerLimit': '69', 'upperLimit': '76'}]}]}, {'title': 'Diastolic, D60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000', 'lowerLimit': '68', 'upperLimit': '77'}]}]}, {'title': 'Diastolic, D180 H0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '69', 'groupId': 'OG001', 'lowerLimit': '63', 'upperLimit': '71'}]}]}, {'title': 'Diastolic, D180 H6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '68.5', 'groupId': 'OG001', 'lowerLimit': '65', 'upperLimit': '71'}]}]}, {'title': 'Diastolic, D181', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '72', 'groupId': 'OG001', 'lowerLimit': '66', 'upperLimit': '75'}]}]}, {'title': 'Diastolic, D182', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG001', 'lowerLimit': '69', 'upperLimit': '72'}]}]}, {'title': 'Diastolic, D187', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '72', 'groupId': 'OG001', 'lowerLimit': '64', 'upperLimit': '77'}]}]}, {'title': 'Diastolic, D210', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '71.5', 'groupId': 'OG001', 'lowerLimit': '65', 'upperLimit': '74'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At Day 0 (PRE), Day 30 (H0, H6) at Day 31, at Day 32, at Day 37, at Day 60 for the HBsAg/AS_2 Group and at Day 0 (PRE), Day 180 (H0, H6), Day 181, at Day 182, at Day 187 and at Day 210 for the Engerix-B_2 Group', 'description': 'Diastolic pressure was part of the list of vital signs followed at specific protocol-defined time points during this study, measured in millimeter of mercury (mmHg). On Days 30 and 180, diastolic blood pressure was assessed at multiple time points (plus 0 and 6 hours - H0, H6).', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.'}, {'type': 'SECONDARY', 'title': 'Levels of Heart Rate - Step 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HBsAg/AS_2 Group', 'description': 'Subjects received, during Step 2 of the study, 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm'}, {'id': 'OG001', 'title': 'Engerix-B_2 Group', 'description': 'Subjects received, during Step 2 of the study, 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}], 'classes': [{'title': 'Heart rate, PRE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000', 'lowerLimit': '63', 'upperLimit': '80'}, {'value': '70', 'groupId': 'OG001', 'lowerLimit': '62', 'upperLimit': '80'}]}]}, {'title': 'Heart rate, D30 H0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000', 'lowerLimit': '65', 'upperLimit': '81'}]}]}, {'title': 'Heart rate, D30 H6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000', 'lowerLimit': '64', 'upperLimit': '77'}]}]}, {'title': 'Heart rate, D31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '84', 'groupId': 'OG000', 'lowerLimit': '70', 'upperLimit': '90'}]}]}, {'title': 'Heart rate, D32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000', 'lowerLimit': '67', 'upperLimit': '83'}]}]}, {'title': 'Heart rate, D37', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000', 'lowerLimit': '56', 'upperLimit': '73'}]}]}, {'title': 'Heart rate, D60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000', 'lowerLimit': '62', 'upperLimit': '72'}]}]}, {'title': 'Heart rate, D180 H0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '71.5', 'groupId': 'OG001', 'lowerLimit': '63', 'upperLimit': '86'}]}]}, {'title': 'Heart rate, D180 H6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG001', 'lowerLimit': '58', 'upperLimit': '80'}]}]}, {'title': 'Heart rate, D181', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '81', 'groupId': 'OG001', 'lowerLimit': '73', 'upperLimit': '91'}]}]}, {'title': 'Heart rate, D182', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '72', 'groupId': 'OG001', 'lowerLimit': '71', 'upperLimit': '83'}]}]}, {'title': 'Heart rate, D187', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '78', 'groupId': 'OG001', 'lowerLimit': '67', 'upperLimit': '84'}]}]}, {'title': 'Heart rate, D210', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '76.5', 'groupId': 'OG001', 'lowerLimit': '68', 'upperLimit': '79'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At Day 0 (PRE), Day 30 (H0, H6) at Day 31, at Day 32, at Day 37, at Day 60 for the HBsAg/AS_2 Group and at Day 0 (PRE), Day 180 (H0, H6), Day 181, at Day 182, at Day 187 and at Day 210 for the Engerix-B_2 Group', 'description': 'Heart rate was part of the list of vital signs followed at specific protocol-defined time points during this study. It was expressed in beats per minute. On Days 30 and 180, heart rate was assessed at multiple time points (plus 0 and 6 hours - H0, H6).', 'unitOfMeasure': 'beats/minute', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.'}, {'type': 'SECONDARY', 'title': 'Levels of Respiratory Rate - Step 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HBsAg/AS_2 Group', 'description': 'Subjects received, during Step 2 of the study, 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm'}, {'id': 'OG001', 'title': 'Engerix-B_2 Group', 'description': 'Subjects received, during Step 2 of the study, 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}], 'classes': [{'title': 'Respiratory rate, PRE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000', 'lowerLimit': '12', 'upperLimit': '14'}, {'value': '12', 'groupId': 'OG001', 'lowerLimit': '12', 'upperLimit': '14'}]}]}, {'title': 'Respiratory rate, D30 H0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.5', 'groupId': 'OG000', 'lowerLimit': '11', 'upperLimit': '13'}]}]}, {'title': 'Respiratory rate, D30 H6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000', 'lowerLimit': '12', 'upperLimit': '14'}]}]}, {'title': 'Respiratory rate, D31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000', 'lowerLimit': '12', 'upperLimit': '14'}]}]}, {'title': 'Respiratory rate, D32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000', 'lowerLimit': '12', 'upperLimit': '13'}]}]}, {'title': 'Respiratory rate, D37', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.5', 'groupId': 'OG000', 'lowerLimit': '12', 'upperLimit': '14'}]}]}, {'title': 'Respiratory rate, D60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000', 'lowerLimit': '12', 'upperLimit': '13'}]}]}, {'title': 'Respiratory rate, D180 H0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.5', 'groupId': 'OG001', 'lowerLimit': '12', 'upperLimit': '15'}]}]}, {'title': 'Respiratory rate, D180 H6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.5', 'groupId': 'OG001', 'lowerLimit': '12', 'upperLimit': '14'}]}]}, {'title': 'Respiratory rate, D181', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG001', 'lowerLimit': '12', 'upperLimit': '14'}]}]}, {'title': 'Respiratory rate, D182', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG001', 'lowerLimit': '12', 'upperLimit': '14'}]}]}, {'title': 'Respiratory rate, D187', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG001', 'lowerLimit': '12', 'upperLimit': '15'}]}]}, {'title': 'Respiratory rate, D210', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.5', 'groupId': 'OG001', 'lowerLimit': '12', 'upperLimit': '15'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At Day 0 (PRE), Day 30 (H0, H6) at Day 31, at Day 32, at Day 37, at Day 60 for the HBsAg/AS_2 Group and at Day 0 (PRE), Day 180 (H0, H6), Day 181, at Day 182, at Day 187 and at Day 210 for the Engerix-B_2 Group', 'description': 'Respiratory Rate was part of the list of vital signs followed at specific protocol-defined time points during this study. It was expressed as breaths per minute (breaths/min). On Days 30 and 180, respiratory rate was assessed at multiple time points (plus 0 and 6 hours - H0, H6).', 'unitOfMeasure': 'breaths/min', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.'}, {'type': 'SECONDARY', 'title': 'Levels of Systolic Pressure - Step 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HBsAg/AS_2 Group', 'description': 'Subjects received, during Step 2 of the study, 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm'}, {'id': 'OG001', 'title': 'Engerix-B_2 Group', 'description': 'Subjects received, during Step 2 of the study, 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}], 'classes': [{'title': 'Systolic, PRE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '114', 'groupId': 'OG000', 'lowerLimit': '110', 'upperLimit': '116'}, {'value': '112', 'groupId': 'OG001', 'lowerLimit': '103', 'upperLimit': '115'}]}]}, {'title': 'Systolic, D30 H0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '114', 'groupId': 'OG000', 'lowerLimit': '109', 'upperLimit': '118'}]}]}, {'title': 'Systolic, D30 H6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '116', 'groupId': 'OG000', 'lowerLimit': '104', 'upperLimit': '121'}]}]}, {'title': 'Systolic, D31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '112', 'groupId': 'OG000', 'lowerLimit': '108', 'upperLimit': '113'}]}]}, {'title': 'Systolic, D32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '111.5', 'groupId': 'OG000', 'lowerLimit': '102', 'upperLimit': '116'}]}]}, {'title': 'Systolic, D37', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '108.5', 'groupId': 'OG000', 'lowerLimit': '105', 'upperLimit': '117'}]}]}, {'title': 'Systolic, D60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '113', 'groupId': 'OG000', 'lowerLimit': '104', 'upperLimit': '122'}]}]}, {'title': 'Systolic, D180 H0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '111.5', 'groupId': 'OG001', 'lowerLimit': '105', 'upperLimit': '119'}]}]}, {'title': 'Systolic, D180 H6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '111.5', 'groupId': 'OG001', 'lowerLimit': '108', 'upperLimit': '114'}]}]}, {'title': 'Systolic, D181', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '115', 'groupId': 'OG001', 'lowerLimit': '112', 'upperLimit': '129'}]}]}, {'title': 'Systolic, D182', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '117', 'groupId': 'OG001', 'lowerLimit': '108', 'upperLimit': '120'}]}]}, {'title': 'Systolic, D187', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '112', 'groupId': 'OG001', 'lowerLimit': '110', 'upperLimit': '115'}]}]}, {'title': 'Systolic, D210', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '112', 'groupId': 'OG001', 'lowerLimit': '108', 'upperLimit': '116'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At Day 0 (PRE), Day 30 (H0, H6) at Day 31, at Day 32, at Day 37, at Day 60 for the HBsAg/AS_2 Group and at Day 0 (PRE), Day 180 (H0, H6), Day 181, at Day 182, at Day 187 and at Day 210 for the Engerix-B_2 Group', 'description': 'Systolic pressure was part of the list of vital signs followed at specific protocol-defined time points during this study, measured in millimeter of mercury (mmHg). On Days 30 and 180, systolic pressure was assessed at multiple time points (plus 0 and 6 hours - H0, H6).', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.'}, {'type': 'SECONDARY', 'title': '-Frequency of Hepatitis B Virus (HBs)-Specific Cluster of Differentiation (CD)4+ T-cells Expressing at Least 2 Immune Markers - Step 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HBsAg/AS_1 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}, {'id': 'OG001', 'title': 'Engerix-B_1 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™- B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}], 'classes': [{'title': 'PRE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '52'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '18'}]}]}, {'title': 'Day 44', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4494', 'groupId': 'OG000', 'lowerLimit': '2441', 'upperLimit': '7494'}, {'value': '268', 'groupId': 'OG001', 'lowerLimit': '76', 'upperLimit': '509'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At Day 0 prior to vaccination (PRE) and Day 44 post-vaccination', 'description': 'Markers expressed were Interleukin-2 (IL-2), Interferon gamma (IFN-γ), Tumor Necrosis Factor (TNF)-α and Cluster of differentiation 40-Ligand (CD40L), as measured by classical (qualified assay) Intracellular Cytokine Staining (ICS),using frozen Peripheral blood mononuclear cells (PBMCs).', 'unitOfMeasure': 'T cells/million cells', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for adaptive immunogenicity up to Day 60 (step 1 only) which included all evaluable subjects who complied with the protocol and for whom data concerning adaptive immunogenicity were available for at least one adaptive assay at one post-vaccination time point (up to Day 60).'}, {'type': 'SECONDARY', 'title': 'Frequency of Hepatitis B Virus (HBs)-Specific Cluster of Differentiation (CD)4+ T-cells Expressing at Least 2 Immune Markers - Step 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HBsAg/AS_1 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the nondominant upper arm.'}, {'id': 'OG001', 'title': 'Engerix-B_1 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™- B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}], 'classes': [{'title': 'PRE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '52'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '21'}]}]}, {'title': 'Day 44', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4494', 'groupId': 'OG000', 'lowerLimit': '2441', 'upperLimit': '7494'}, {'value': '260', 'groupId': 'OG001', 'lowerLimit': '33', 'upperLimit': '527'}]}]}, {'title': 'Day 180', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1119', 'groupId': 'OG000', 'lowerLimit': '748', 'upperLimit': '2181'}, {'value': '34', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '155'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At Day 0 prior to vaccination (PRE), Day 44 and Day 180 post-vaccination', 'description': 'Markers expressed were Interleukin-2 (IL-2), Interferon gamma (IFN-γ), Tumor Necrosis Factor (TNF)-α and Cluster of differentiation 40-Ligand (CD40L), as measured by classical (qualified assay) Intracellular Cytokine Staining (ICS),using frozen Peripheral blood mononuclear cells (PBMCs).', 'unitOfMeasure': 'T cells/ million cells', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol (ATP) cohort for persistence (step 1 only) included all evaluable subjects, who complied with the protocol, for whom data concerning adaptive immunogenicity were available for at least one adaptive assay at Day 180.'}, {'type': 'SECONDARY', 'title': 'Frequency of Hepatitis B Virus (HBs)-Specific Cluster of Differentiation (CD)8+ T-cells Expressing at Least 2 Immune Markers - Step 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HBsAg/AS_1 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}, {'id': 'OG001', 'title': 'Engerix-B_1 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™- B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}], 'classes': [{'title': 'PRE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '24'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '1'}]}]}, {'title': 'Day 44', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '108'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '33'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At Day 0 prior to vaccination (PRE) and Day 44 post-vaccination', 'description': 'Markers expressed were Interleukin-2 (IL-2), Interferon gamma (IFN-γ), Tumor Necrosis Factor (TNF)-α and Cluste of differentiation 40-Ligand (CD40L), as measured by classical (qualified assay) Intracellular Cytokine Staining (ICS),using frozen Peripheral blood mononuclear cells (PBMCs).', 'unitOfMeasure': 'T cells/ million cells', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for adaptive immunogenicity up to Day 60 (step 1 only) which included all evaluable subjects who complied with the protocol and for whom data concerning adaptive immunogenicity were available for at least one adaptive assay at one post-vaccination time point (up to Day 60).'}, {'type': 'SECONDARY', 'title': 'Frequency of Hepatitis B Virus (HBs)-Specific Cluster of Differentiation (CD)8+ T-cells Expressing at Least 2 Immune Markers - Step 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HBsAg/AS_1 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}, {'id': 'OG001', 'title': 'Engerix-B_1 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™- B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}], 'classes': [{'title': 'PRE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '24'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '1'}]}]}, {'title': 'Day 44', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '108'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '42'}]}]}, {'title': 'Day 180', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '17'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '31'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At Day 0 prior to vaccination (PRE), Day 44 and Day 180 post-vaccination', 'description': 'Markers expressed were Interleukin-2 (IL-2), Interferon gamma (IFN-γ), Tumor Necrosis Factor (TNF)-α and Cluster of differentiation 40-Ligand (CD40L), as measured by classical (qualified assay) Intracellular Cytokine Staining (ICS),using frozen Peripheral blood mononuclear cells (PBMCs).', 'unitOfMeasure': 'T ceclls/ million cells', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-To-Protocol (ATP) cohort for persistence (step 1 only) included all evaluable subjects, who complied with the protocol, for whom data concerning adaptive immunogenicity were available for at least one adaptive assay at Day 180.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HBsAg/AS_2 Group', 'description': 'Subjects received, during Step 2 of the study, 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}, {'id': 'OG001', 'title': 'Engerix-B_2 Group', 'description': 'Subjects received, during Step 2 of the study, 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}], 'classes': [{'title': 'Pain, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Pain, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Redness, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Redness, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Swelling, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Swelling, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Induration, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Induration, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Fever, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Fever, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Muscle stiffness, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Muscle stiffness, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 3 days post-placebo/vaccine administration.', 'description': 'Assessed solicited symptoms were fever \\[defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)\\], pain, redness \\[spreading beyond 20 millimeters (mm) of injection site\\], induration \\[spreading beyond 20 millimeters (mm) of injection site\\], swelling \\[spreading beyond 20 millimeters (mm) of injection site\\] and muscle stiffness.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Pooling Step', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HBsAg/AS_1+2 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30; or during Step 2 of the study, 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}], 'classes': [{'title': 'Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}]}]}, {'title': 'Redness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'Swelling', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Induration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Muscle stiffness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 3 days post-Dose 2 vaccine administration in HBsAg/AS_1+2 Group', 'description': 'Assessed solicited symptoms were fever \\[defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)\\], pain, redness \\[spreading beyond 20 millimeters (mm) of injection site\\], induration \\[spreading beyond 20 millimeters (mm) of injection site\\], swelling \\[spreading beyond 20 millimeters (mm) of injection site\\] and muscle stiffness.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, of the HBsAg/AS\\_1+2 Group only, which included all subjects with the vaccine administration documented.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'HBsAg/AS_1+2 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30; or during Step 2 of the study, 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}, {'id': 'FG001', 'title': 'Engerix-B_1+2 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180; or during Step 2 of the study, 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '41'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '38'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Personal problem', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Investigator call for AEs check', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'HBsAg/AS_1+2 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30; and during Step 2 of the study, 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}, {'id': 'BG001', 'title': 'Engerix-B_1+2 Group', 'description': 'Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180; and during Step 2 of the study, 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '39.2', 'spread': '4.1', 'groupId': 'BG000'}, {'value': '37.5', 'spread': '5.9', 'groupId': 'BG001'}, {'value': '38.4', 'spread': '5.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Geographic ancestry', 'categories': [{'title': 'African Heritage / African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White - Arabic / North African Heritage', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'White - Caucasian / European Heritage', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 81}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2016-09-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-29', 'studyFirstSubmitDate': '2013-01-24', 'resultsFirstSubmitDate': '2017-05-17', 'studyFirstSubmitQcDate': '2013-01-24', 'lastUpdatePostDateStruct': {'date': '2019-01-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-06-29', 'studyFirstPostDateStruct': {'date': '2013-01-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-01-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-05-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Concentrations of Cytokines and Chemokines - Step 1', 'timeFrame': 'At Day -30 prior to placebo administration', 'description': 'Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.'}, {'measure': 'Cytokines and Chemokines Concentrations - Step 1', 'timeFrame': 'Post-placebo at Day -30 plus 1.5 Hours', 'description': 'Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.'}, {'measure': 'Concentrations of Cytokines and Chemokines in Step 1', 'timeFrame': 'Post-placebo at Day -30 plus 3 Hours', 'description': 'Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.'}, {'measure': 'Concentrations of Cytokines and Chemokines During Step 1', 'timeFrame': 'Post-placebo at Day -30 plus 6 Hours', 'description': 'Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.'}, {'measure': 'Concentrations of Cytokines/Chemokines - Step 1', 'timeFrame': 'Post-placebo at Day -30 plus 9 Hours', 'description': 'Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.'}, {'measure': 'Concentrations of Cytokines/Chemokines in Step 1', 'timeFrame': 'Post-placebo at Day -30 plus 12 Hours', 'description': 'Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.'}, {'measure': 'Concentrations of Cytokines/Chemokines During Step 1', 'timeFrame': 'Post-placebo at Day -30 plus 18 Hours', 'description': 'Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.'}, {'measure': 'Cytokines and Chemokines Concentrations in Step 1', 'timeFrame': 'Post-placebo at Day -29', 'description': 'Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.'}, {'measure': 'Cytokines and Chemokines Concetrations During Step 1', 'timeFrame': 'Post-placebo at Day -28', 'description': 'Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.'}, {'measure': 'Cytokines/Chemokines Concentrations in Step 1', 'timeFrame': 'Post-placebo at Day -27', 'description': 'Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.'}, {'measure': 'Cytokines and Chemokines Concentrations During Step 1', 'timeFrame': 'Post-placebo at Day -23', 'description': 'Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.'}, {'measure': 'Concentrations of Cytokines and Chemokines - Study Step 1', 'timeFrame': 'Pre-dose1 at Day 0', 'description': 'Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.'}, {'measure': 'Concentrations of Cytokines and Chemokines in Step 1 of Study', 'timeFrame': 'Post-dose1 at Day 0 plus 1.5 Hours', 'description': 'Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.'}, {'measure': 'Concentrations of Cytokines and Chemokines During Step 1 of Study', 'timeFrame': 'Post-dose1 at Day 0 plus 6 Hours', 'description': 'Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.'}, {'measure': 'Cytokines and Chemokines Concentrations - Study Step 1', 'timeFrame': 'Post-dose1 at Day 0 plus 12 Hours', 'description': 'Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.'}, {'measure': 'Cytokines and Chemokines Concentrations in Step 1 of Study', 'timeFrame': 'Post-dose1 at Day 0 plus 18 Hours', 'description': 'Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.'}, {'measure': 'Cytokines and Chemokines Concentrations During Step 1 of Study', 'timeFrame': 'Post-dose1 at Day 1', 'description': 'Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.'}, {'measure': 'Cytokines/Chemokines Concentrations - Study Step 1', 'timeFrame': 'Post-dose1 at Day 2', 'description': 'Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.'}, {'measure': 'Cytokines/Chemokines Concentrations in Step 1 of Study', 'timeFrame': 'Post-dose1 at Day 7', 'description': 'Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.'}, {'measure': 'Cytokines/Chemokines Concentrations During Step 1 of Study', 'timeFrame': 'Post-dose1 at Day 30', 'description': 'Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.'}, {'measure': 'Plasma Concentrations of Cytokines and Chemokines - Step 1', 'timeFrame': 'Post-dose 2 at Day 30 plus 1.5 Hours', 'description': 'Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.'}, {'measure': 'Plasma Concentrations of Cytokines and Chemokines - Study Step 1', 'timeFrame': 'Post-dose 2 at Day 30 plus 3 Hours', 'description': 'Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.'}, {'measure': 'Plasma Concentrations of Cytokines and Chemokines in Step 1 of Study', 'timeFrame': 'Post-dose 2 at Day 30 plus 6 hours', 'description': 'Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.'}, {'measure': 'Plasma Concentrations of Cytokines and Chemokines During Step 1 of Study', 'timeFrame': 'Post-dose 2 at Day 30 plus 9 Hours', 'description': 'Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.'}, {'measure': 'Plasma Concentrations of Cytokines/Chemokines During Step 1 of Study', 'timeFrame': 'Post-dose 2 at Day 30 plus 12 Hours', 'description': 'Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.'}, {'measure': 'Plasma Concentrations of Cytokines/Chemokines - Step 1 of Study', 'timeFrame': 'Post-dose 2 at Day 30 plus 18 Hours', 'description': 'Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.'}, {'measure': 'Plasma Concentrations of Cytokines/Chemokines in Step 1 of Study', 'timeFrame': 'Post-dose 2 at Day 31', 'description': 'Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.'}, {'measure': 'Concentrations of Plasma Cytokines and Chemokines - Step 1', 'timeFrame': 'Post-dose 2 at Day 32', 'description': 'Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.'}, {'measure': 'Concentrations of Plasma Cytokines and Chemokines in Step 1', 'timeFrame': 'Post-dose 2 at Day 33', 'description': 'Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.'}, {'measure': 'Concentrations of Plasma Cytokines and Chemokines During Step 1', 'timeFrame': 'Post-dose 2 at Day 37', 'description': 'Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.'}, {'measure': 'Concentrations of Cytokines and Chemokines - Step 2', 'timeFrame': 'Pre-dose 1 at Day 0', 'description': 'Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.'}, {'measure': 'Cytokines and Chemokines Concentrations - Step 2', 'timeFrame': 'Post-dose 1 at Day 1', 'description': 'Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma. The analysis was performed only on the HBsAg/AS\\_2 Group.'}, {'measure': 'Concentrations of Cytokines and Chemokines During Step 2', 'timeFrame': 'Post-dose 1 at Day 30', 'description': 'Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma. The analysis was performed only on the HBsAg/AS\\_2 Group.'}, {'measure': 'Concentrations of Cytokines and Chemokines in Step 2', 'timeFrame': 'Post-dose2 at Day 30 plus 6 Hours', 'description': 'Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma. The analysis was performed only on the HBsAg/AS\\_2 Group.'}, {'measure': 'Concentrations of Cytokines/Chemokines - Step 2', 'timeFrame': 'Post-dose 2 at Day 31', 'description': 'Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma. The analysis was performed only on the HBsAg/AS\\_2 Group.'}, {'measure': 'Concentrations of Cytokines/Chemokines in Step 2', 'timeFrame': 'Post-dose 2 at Day 37', 'description': 'Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.\n\nThe analysis was performed only on the HBsAg/AS\\_2 Group.'}, {'measure': 'Concentrations of Cytokines/Chemokines During Step 2', 'timeFrame': 'Post-dose 2 at Day 180', 'description': 'Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.\n\nThe analysis was performed only on the Engerix-B\\_2 Group.'}, {'measure': 'Plasma Concentrations of Cytokines and Chemokines - Study Step 2', 'timeFrame': 'Post-dose 3 at Day 180 plus 6 Hours', 'description': 'Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.The analysis was performed only on theEngerix-B\\_2 Group.'}, {'measure': 'Plasma Concentrations of Cytokines and Chemokines in Step 2 of Study', 'timeFrame': 'Post-dose 3 at Day 181', 'description': 'Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma. The analysis was performed only on the Engerix-B\\_2 Group.'}, {'measure': 'Plasma Concentrations of Cytokines and Chemokines During Step 2 of Study', 'timeFrame': 'Post-dose 3 at Day 187', 'description': 'Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma. The analysis was performed only on the Engerix-B\\_2 Group.'}], 'secondaryOutcomes': [{'measure': 'Anti-Hepatitis B Surface (Anti-HBs) Antibody Concentrations in Serum - Step 1', 'timeFrame': 'At Day 0 (PRE) and Day 60 (D60) post-vaccination', 'description': 'Anti-HBs antibody concentrations in serum were measured by Chemi Luminiscence Immuno Assay (CLIA). Concentrations were presented as geometric mean concentrations, in milli-International Units per milliliter (mIU/mL).'}, {'measure': 'Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 1', 'timeFrame': 'During the 7-day (Days 0-6) post-placebo (PP) and post-vaccination period following each vaccine dose (D1 and D2) and across doses', 'description': 'Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.'}, {'measure': 'Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1', 'timeFrame': 'During the 7-day (Days 0-6) post-placebo (PP) and post-vaccination period following each vaccine dose (D1 and D2) and across doses', 'description': 'Assessed solicited general symptoms were fatigue, gastrointestinal symptoms \\[nausea, vomiting, diarrhoea and /or abdominal pain\\], headache, malaise, myalgia, shivering and temperature \\[defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)\\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \\> 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination'}, {'measure': 'Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 1', 'timeFrame': 'Up to 4 days post-placebo/vaccine administration.', 'description': 'Assessed solicited symptoms were fever \\[defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)\\], pain, redness \\[spreading beyond 20 millimeters (mm) of injection site\\], induration \\[spreading beyond 20 millimeters (mm) of injection site\\], swelling \\[spreading beyond 20 millimeters (mm) of injection site\\] and muscle stiffness.'}, {'measure': 'Number of Subjects With Any Unsolicited Adverse Events (AEs) - Step 1', 'timeFrame': 'Within the 28-day (Days 0-27) post-placebo (PP) and post-product administration period.', 'description': 'An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset out-side the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.'}, {'measure': 'Number of Subjects With Serious Adverse Events (SAEs) - Step 1', 'timeFrame': 'From Day 0 up to Day 60 for the HBsAg/AS_1 Group and from Day 0 up to Day 210 for the Engerix-B_1 Group', 'description': 'Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.'}, {'measure': 'Number of Subjects With Any Potential Immune-mediated Disorders (pIMDs) - Step 1', 'timeFrame': 'From Day 0 up to Day 60 for the HBsAg/AS_1 Group and from Day 0 up to Day 210 for the Engerix-B_1 Group', 'description': 'PIMD(s) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.'}, {'measure': 'Number of Subjects With Any New Medical Conditions Requiring Medical Attention (MAEs) - Step 1', 'timeFrame': 'From Day 0 up to Day 60 for the HBsAg/AS_1 Group and from Day 0 up to Day 210 for the Engerix-B_1 Group', 'description': 'MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination. Analysis of intensity and relationship to vaccination of MAEs was not performed.'}, {'measure': 'Levels of Alanine Aminotransferase (ALT) in Blood Samples - Step 1', 'timeFrame': 'At Day 0, Day 0 H6, Day 0 H12, Day 0 H18, Day 1, Day 7, Day 30, Day 30 H6, Day 30 H12, Day 30 H18, Day 31, Day 37 and Day 60', 'description': 'Biochemical laboratory parameters assessed included ALT levels. ALT concentrations were expressed in units per liter (U/L). ALT levels were assessed at different time points (plus 6, 12 and 18 hours - H6, H12, H18) on Day 0 and Day 30.'}, {'measure': 'Levels of Aspartate Aminotransferase (AST) in Blood Samples - Step 1', 'timeFrame': 'At Day 0, Day 0 H6, Day 0 H12, Day 0 H18, Day 1, Day 7, Day 30, Day 30 H6, Day 30 H12, Day 30 H18, Day 31, Day 37 and Day 60', 'description': 'Biochemical laboratory parameters assessed included AST levels. AST concentrations were expressed in units per liter (U/L). AST levels were assessed at different time points (plus 6, 12 and 18 hours - H6, H12, H18) on Day 0 and Day 30.'}, {'measure': 'Levels of Basophils in Blood Samples - Step 1', 'timeFrame': 'At Day 0, Day 0 H6, Day 0 H12, Day 0 H18, Day 1, Day 7, Day 30, Day 30 H6, Day 30 H12, Day 30 H18, Day 31, Day 37 and Day 60', 'description': 'Haematological laboratory parameters assessed included basophil levels. Basophil levels were expressed in billion cells per liter (billion cells/L). Basophil levels were assessed at different time points (plus 6, 12 and 18 hours - H6, H12, H18) on Day 0 and Day 30.'}, {'measure': 'Levels of Total Bilirubin in Blood Samples - Step 1', 'timeFrame': 'At Day 0, Day 0 H6, Day 0 H12, Day 0 H18, Day 1, Day 7, Day 30, Day 30 H6, Day 30 H12, Day 30 H18, Day 31, Day 37 and Day 60', 'description': 'Biochemical laboratory parameters assessed included total bilirubin levels. Bilirubin concentrations were expressed in milligrams per deciliter (mG/dL). Bilirubin levels were assessed at different time points (plus 6, 12 and 18 hours - H6, H12, H18) on Day 0 and Day 30.'}, {'measure': 'Levels of Serum Creatinine in Blood Samples - Step 1', 'timeFrame': 'At Day 0, Day 0 H6, Day 0 H12, Day 0 H18, Day 1, Day 7, Day 30, Day 30 H6, Day 30 H12, Day 30 H18, Day 31, Day 37 and Day 60', 'description': 'Biochemical laboratory parameters assessed included creatinine levels. Creatinine concentrations were expressed in milligrams per deciliter (mg/dL). Creatinine levels were assessed at different time points (plus 6, 12 and 18 hours - H6, H12, H18) on Day 0 and Day 30.'}, {'measure': 'Levels of Creatinine Phosphokinase (CPK) in Blood Samples - Step 1', 'timeFrame': 'At Day 0, Day 0 H6, Day 0 H12, Day 0 H18, Day 1, Day 7, Day 30, Day 30 H6, Day 30 H12, Day 30 H18, Day 31, Day 37 and Day 60', 'description': 'Biochemical laboratory parameters assessed included CPK levels. CPK concentrations were expressed in milligrams per deciliter (mg/dL). CPK levels were assessed at different time points (plus 6, 12 and 18 hours - H6, H12, H18) on Day 0 and Day 30.'}, {'measure': 'Levels of C-reactive Protein (CRP) in Blood Samples - Step 1', 'timeFrame': 'At Day 0, Day 0 H6, Day 0 H12, Day 0 H18, Day 1, Day 7, Day 30, Day 30 H6, Day 30 H12, Day 30 H18, Day 31, Day 37 and Day 60', 'description': 'Biochemical laboratory parameters assessed included CRP levels. CRP concentrations were expressed in milligrams per liter (mg/L). CRP levels were assessed at different time points (plus 6, 12 and 18 hours - H6, H12, H18) on Day 0 and Day 30.'}, {'measure': 'Levels of Eosinophils in Blood Samples - Step 1', 'timeFrame': 'At Day 0, Day 0 H6, Day 0 H12, Day 0 H18, Day 1, Day 7, Day 30, Day 30 H6, Day 30 H12, Day 30 H18, Day 31, Day 37 and Day 60', 'description': 'Haematological laboratory parameters assessed included eosinophil levels. Eosinophil levels were expressed in billion cells per liter (billion cells/L). Eosinophil levels were assessed at different time points (plus 6, 12 and 18 hours - H6, H12, H18) on Day 0 and Day 30.'}, {'measure': 'Levels of Haemoglobin in Blood Samples - Step 1', 'timeFrame': 'At Day 0, Day 0 H6, Day 0 H12, Day 0 H18, Day 1, Day 7, Day 30, Day 30 H6, Day 30 H12, Day 30 H18, Day 31, Day 37 and Day 60', 'description': 'Haematological laboratory parameters assessed included haemoglobin levels, expressed in grams per deciliter (g/dL). Haemoglobin levels were assessed at different time points (plus 6, 12 and 18 hours - H6, H12, H18) on Day 0 and Day 30.'}, {'measure': 'Levels of Lactate Dehydrogenase (LDH) in Blood Samples - Step 1', 'timeFrame': 'At Day 0, Day 0 H6, Day 0 H12, Day 0 H18, Day 1, Day 7, Day 30, Day 30 H6, Day 30 H12, Day 30 H18, Day 31, Day 37 and Day 60', 'description': 'Biochemical laboratory parameters assessed included LDH levels, expressed in units per liter (U/L). LDH levels were assessed at different time points (plus 6, 12 and 18 hours - H6, H12, H18) on Day 0 and Day 30.'}, {'measure': 'Levels of Lymphocytes in Blood Samples - Step 1', 'timeFrame': 'At Day 0, Day 0 H6, Day 0 H12, Day 0 H18, Day 1, Day 7, Day 30, Day 30 H6, Day 30 H12, Day 30 H18, Day 31, Day 37 and Day 60', 'description': 'Haematological laboratory parameters assessed included lymphocyte levels. Lymphocyte levels were expressed in billion cells per liter (billion cells/L). Lymphocyte levels were assessed at different time points (plus 6, 12 and 18 hours - H6, H12, H18) on Day 0 and Day 30.'}, {'measure': 'Levels of Monocytes in Blood Samples - Step 1', 'timeFrame': 'At Day 0, Day 0 H6, Day 0 H12, Day 0 H18, Day 1, Day 7, Day 30, Day 30 H6, Day 30 H12, Day 30 H18, Day 31, Day 37 and Day 60', 'description': 'Haematological laboratory parameters assessed included monocyte levels. Monocyte levels were expressed in billion cells per liter (billion cells/L). Monocyte levels were assessed at different time points (plus 6, 12 and 18 hours - H6, H12, H18) on Day 0 and Day 30.'}, {'measure': 'Levels of Neutrophils in Blood Samples - Step 1', 'timeFrame': 'At Day 0, Day 0 H6, Day 0 H12, Day 0 H18, Day 1, Day 7, Day 30, Day 30 H6, Day 30 H12, Day 30 H18, Day 31, Day 37 and Day 60', 'description': 'Haematological laboratory parameters assessed included neutrophil levels. Neutrophil levels were expressed in billion cells per liter (billion cells/L). Neutrophil levels were assessed at different time points (plus 6, 12 and 18 hours - H6, H12, H18) on Day 0 and Day 30.'}, {'measure': 'Platelet Count in Blood Samples - Step 1', 'timeFrame': 'At Day 0, Day 0 H6, Day 0 H12, Day 0 H18, Day 1, Day 7, Day 30, Day 30 H6, Day 30 H12, Day 30 H18, Day 31, Day 37 and Day 60', 'description': 'Haematological laboratory parameters assessed included platelet count levels. Platelet count levels were expressed in billion cells per liter (billion cells/L). Platelet count levels were assessed at different time points (plus 6, 12 and 18 hours - H6, H12, H18) on Day 0 and Day 30.'}, {'measure': 'Levels of Red Blood Cell (RBC) in Blood Samples - Step 1', 'timeFrame': 'At Day 0, Day 0 H6, Day 0 H12, Day 0 H18, Day 1, Day 7, Day 30, Day 30 H6, Day 30 H12, Day 30 H18, Day 31, Day 37 and Day 60', 'description': 'Haematological laboratory parameters assessed included red blood cells levels, expressed in trillion cells per liter (trillion cells/L). RBC levels were assessed at different time points (plus 6, 12 and 18 hours - H6, H12, H18) on Day 0 and Day 30.'}, {'measure': 'Levels of Urea in Blood Samples - Step 1', 'timeFrame': 'At Day 0, Day 0 H6, Day 0 H12, Day 0 H18, Day 1, Day 7, Day 30, Day 30 H6, Day 30 H12, Day 30 H18, Day 31, Day 37 and Day 60', 'description': 'Biochemical laboratory parameters assessed included urea levels, expressed in miligrams per deciliter (mg/dL). Urea levels were assessed at different time points (plus 6, 12 and 18 hours - H6, H12, H18) on Day 0 and Day 30.'}, {'measure': 'Levels of White Blood Cells (WBC) - Step 1', 'timeFrame': 'At Day 0, Day 0 H6, Day 0 H12, Day 0 H18, Day 1, Day 7, Day 30, Day 30 H6, Day 30 H12, Day 30 H18, Day 31, Day 37 and Day 60', 'description': 'Haematological laboratory parameters assessed included WBC levels. WBC levels were expressed in billion cells per liter (billion cells/L). WBC levels were assessed at different time points (plus 6, 12 and 18 hours - H6, H12, H18) on Day 0 and Day 30.'}, {'measure': 'Levels of Diastolic Blood Pressure - Step 1', 'timeFrame': 'At Day -30, -30 (H1.5, H3, H6, H9, H12, H18) -29, - 28, - 27, -23, 0, 0 (H1.5, H6, H12 H18), 1, 2, 7, 30, 30 (H1.5, H3, H6, H9, H12, H18), 31, 32, 33, 37 and 60', 'description': 'Diastolic pressure was part of the list of vital signs followed at specific protocol-defined time points during this study, measured in millimeter of mercury (mmHg). On Days -30, 0 and 30, diastolic blood pressure was assessed at multiple time points (plus 1.5, 3, 6, 9, 12 and 18 hours - H1.5, H3, H6, H9, H12 and H18).'}, {'measure': 'Levels of Heart Rate - Step 1', 'timeFrame': 'At Day -30, -30 (H1.5, H3, H6, H9, H12, H18) -29, - 28, - 27, -23, 0, 0 (H1.5, H6, H12 H18), 1, 2, 7, 30, 30 (H1.5, H3, H6, H9, H12, H18), 31, 32, 33, 37 and 60', 'description': 'Heart rate was part of the list of vital signs followed at specific protocol-defined timepoints during this study. It was expressed in beats per minute. On Days -30, 0 and 30, heart rate was assessed at multiple time points (plus 1.5, 3, 6, 9, 12 and 18 hours - H1.5, H3, H6, H9, H12 and H18).'}, {'measure': 'Levels of Respiratory Rate - Step 1', 'timeFrame': 'At Day -30, -30 (H1.5, H3, H6, H9, H12, H18) -29, - 28, - 27, -23, 0, 0 (H1.5, H6, H12 H18), 1, 2, 7, 30, 30 (H1.5, H3, H6, H9, H12, H18), 31, 32, 33, 37 and 60', 'description': 'Respiratory Rate was part of the list of vital signs followed at specific protocol-defined timepoints during this study. It was expressed as breaths per minute (breaths/min). On Days -30, 0 and 30, respiratory rate was assessed at multiple time points (plus 1.5, 3, 6, 9, 12 and 18 hours - H1.5, H3, H6, H9, H12 and H18).'}, {'measure': 'Levels of Systolic Pressure - Step 1', 'timeFrame': 'At Day -30, -30 (H1.5, H3, H6, H9, H12, H18) -29, - 28, - 27, -23, 0, 0 (H1.5, H6, H12 H18), 1, 2, 7, 30, 30 (H1.5, H3, H6, H9, H12, H18), 31, 32, 33, 37 and 60', 'description': 'Systolic pressure was part of the list of vital signs followed at specific protocol-defined time points during this study, measured in millimeter of mercury (mmHg). On Days -30, 0 and 30, systolic pressure was assessed at multiple time points (plus 1.5, 3, 6, 9, 12 and 18 hours - H1.5, H3, H6, H9, H12 and H18).'}, {'measure': 'Anti-Hepatitis B Surface (Anti-HBs) Antibody Concentrations in Serum - Step 2 Immuno', 'timeFrame': 'At Day 0 (PRE) and post-vaccination (Day 44 for HBsAg/AS_2 Group and Day 194 for Engerix-B_2 Group)', 'description': 'Anti-HBs antibody concentrations in serum were measured by CLIA Assay. Concentrations were presented as geometric mean concentrations, in milli-International Units per milliliter (mIU/mL).'}, {'measure': 'Anti-Hepatitis B Surface (Anti-HBs) Antibody Concentrations in Serum - Step 2 Persistence', 'timeFrame': 'At Day 0 (PRE) and post-vaccination (Day 44 for HBsAg/AS_2 Group and Day 194 for Engerix-B_2 Group)', 'description': 'Anti-HBs antibody concentrations in serum were measured by CLIA Assay. Concentrations were presented as geometric mean concentrations, in milli-International Units per milliliter (mIU/mL).'}, {'measure': 'Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 2', 'timeFrame': 'During the 7-day (Days 0-6) post-vaccination period following each vaccine dose and across doses', 'description': 'Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.'}, {'measure': 'Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Pooling Step', 'timeFrame': 'During the 7-day (Days 0-6) post-vaccination period following each vaccine dose and across doses', 'description': 'Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.'}, {'measure': 'Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2', 'timeFrame': 'During the 7-day (Days 0-6) post-vaccination period following each vaccine dose and across doses', 'description': 'Assessed solicited general symptoms were fatigue, gastrointestinal symptoms \\[nausea, vomiting, diarrhoea and/or abdominal pain\\], headache, malaise, myalgia, shivering and temperature \\[defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)\\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \\> 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination. At Day 0 of dose 2, two temperatures were collected: one at Hour 0 (H0) and a second one at Hour 18 (H18). The highest temperature between H0 et H18 was taken.'}, {'measure': 'Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step', 'timeFrame': 'During the 7-day (Days 0-6) post-vaccination period following each vaccine dose and across doses', 'description': 'Assessed solicited general symptoms were fatigue, gastrointestinal symptoms \\[nausea, vomiting, diarrhoea and/or abdominal pain\\], headache, malaise, myalgia, shivering and temperature \\[defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)\\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \\> 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination. There was no pooling for temperature symptom between Step 1 and Step 2 due to difference in recording approach for the 18 hour data (nurse or self-assessment).'}, {'measure': 'Number of Subjects With Any Unsolicited Adverse Events (AEs) - Step 2', 'timeFrame': 'Within the 28-day (Days 0-27) and post-vaccination period', 'description': 'An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset out-side the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.'}, {'measure': 'Number of Subjects With Any Unsolicited Adverse Events (AEs) - Pooling Step', 'timeFrame': 'Within the 28-day (Days 0-27) post-vaccination period.', 'description': 'An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset out-side the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.'}, {'measure': 'Number of Subjects With Serious Adverse Events (SAEs) - Step 2', 'timeFrame': 'Up to Day 180 for the HBsAg/AS_2 Group and up to Day 330 for the Engerix-B_2 Group', 'description': 'Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.'}, {'measure': 'Number of Subjects With Serious Adverse Events (SAEs) - Pooling Step', 'timeFrame': 'Up to Day 180 for the HBsAg/AS_1+2 Group and up to Day 330 for the Engerix-B_1+2 Group', 'description': 'Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.'}, {'measure': 'Number of Subjects With Any Potential Immune-mediated Disorders (pIMDs) - Step 2', 'timeFrame': 'Up to Day 180 for the HBsAg/AS_2 Group and up to Day 330 for the Engerix-B_2 Group', 'description': 'PIMD(s) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.'}, {'measure': 'Number of Subjects With Any Potential Immune-mediated Disorders (pIMDs) - Pooling Step', 'timeFrame': 'Up to Day 180 for the HBsAg/AS_1+2 Group and up to Day 330 for the Engerix-B_1+2 Group', 'description': 'PIMD(s) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.'}, {'measure': 'Number of Subjects With Any New Medical Conditions Requiring Medical Attention (MAEs) - Step 2', 'timeFrame': 'Up to Day 180 for the HBsAg/AS_2 Group and up to Day 330 for the Engerix-B_2 Group', 'description': 'MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.'}, {'measure': 'Number of Subjects With Any New Medical Conditions Requiring Medical Attention (MAEs) - Pooling Step', 'timeFrame': 'Up to Day 180 for the HBsAg/AS_1+2 Group and up to Day 330 for the Engerix-B_1+2 Group', 'description': 'MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.'}, {'measure': 'Levels of Alanine Aminotransferase (ALT) in Blood Samples - Step 2', 'timeFrame': 'At Day 0 (PRE), Day 30, Day 32, Day 37, Day 60 for the HBsAg/AS_2 Group and Day 0 (PRE) Day 180, Day 182, Day 187 and Day 210 for the Engerix-B_2 Group', 'description': 'Biochemical laboratory parameters assessed included ALT levels. ALT concentrations were expressed in units per liter (U/L).'}, {'measure': 'Levels of Aspartate Aminotransferase (AST) in Blood Samples - Step 2', 'timeFrame': 'At Day 0 (PRE), Day 30, Day 32, Day 37, Day 60 for the HBsAg/AS_2 Group and Day 0 (PRE) Day 180, Day 182, Day 187 and Day 210 for the Engerix-B_2 Group', 'description': 'Biochemical laboratory parameters assessed included AST levels. AST concentrations were expressed in units per liter (U/L).'}, {'measure': 'Levels of Basophils in Blood Samples - Step 2', 'timeFrame': 'At Day 0 (PRE), Day 30, Day 32, Day 37, Day 60 for the HBsAg/AS_2 Group and Day 0 (PRE) Day 180, Day 182, Day 187 and Day 210 for the Engerix-B_2 Group', 'description': 'Haematological laboratory parameters assessed included basophil levels. Basophil levels were expressed in billion cells per liter (billion cells/L).'}, {'measure': 'Levels of Serum C Reactive Protein (CRP) in Blood Samples - Step 2', 'timeFrame': 'At Day 0 (PRE), Day 30, Day 32, Day 37, Day 60 for the HBsAg/AS_2 Group and Day 0 (PRE) Day 180, Day 182, Day 187 and Day 210 for the Engerix-B_2 Group', 'description': 'Biochemical laboratory parameters assessed included CRP levels. CRP concentrations were expressed in milligrams per liter (mg/L).'}, {'measure': 'Levels of Eosinophils in Blood Samples - Step 2', 'timeFrame': 'At Day 0 (PRE), Day 30, Day 32, Day 37, Day 60 for the HBsAg/AS_2 Group and Day 0 (PRE) Day 180, Day 182, Day 187 and Day 210 for the Engerix-B_2 Group', 'description': 'Haematological laboratory parameters assessed included eosinophil levels. Eosinophil levels were expressed in billion cells per liter (billion cells/L).'}, {'measure': 'Levels of White Blood Cell (WBC) in Blood Samples - Step 2', 'timeFrame': 'At Day 0 (PRE), Day 30, Day 32, Day 37, Day 60 for the HBsAg/AS_2 Group and Day 0 (PRE) Day 180, Day 182, Day 187 and Day 210 for the Engerix-B_2 Group', 'description': 'Haematological laboratory parameters assessed included white blood cells levels. WBC levels were expressed in billion cells per liter (billion cells/L).'}, {'measure': 'Levels of Lymphocytes in Blood Samples - Step 2', 'timeFrame': 'At Day 0 (PRE), Day 30, Day 32, Day 37, Day 60 for the HBsAg/AS_2 Group and Day 0 (PRE) Day 180, Day 182, Day 187 and Day 210 for the Engerix-B_2 Group', 'description': 'Haematological laboratory parameters assessed included lymphocyte levels. Lymphocyte levels were expressed in billion cells per liter (billion cells/L).'}, {'measure': 'Levels of Monocytes in Blood Samples - Step 2', 'timeFrame': 'At Day 0 (PRE), Day 30, Day 32, Day 37, Day 60 for the HBsAg/AS_2 Group and Day 0 (PRE) Day 180, Day 182, Day 187 and Day 210 for the Engerix-B_2 Group', 'description': 'Haematological laboratory parameters assessed included monocyte levels. Monocyte levels were expressed in billion cells per liter (billion cells/L).'}, {'measure': 'Levels of Neutrophils in Blood Samples - Step 2', 'timeFrame': 'At Day 0 (PRE), Day 30, Day 32, Day 37, Day 60 for the HBsAg/AS_2 Group and Day 0 (PRE) Day 180, Day 182, Day 187 and Day 210 for the Engerix-B_2 Group', 'description': 'Haematological laboratory parameters assessed included neutrophil levels. Neutrophil levels were expressed in billion cells per liter (billion cells/L).'}, {'measure': 'Platelet Count in Blood Samples - Step 2', 'timeFrame': 'At Day 0 (PRE), Day 30, Day 32, Day 37, Day 60 for the HBsAg/AS_2 Group and Day 0 (PRE) Day 180, Day 182, Day 187 and Day 210 for the Engerix-B_2 Group', 'description': 'Haematological laboratory parameters assessed included platelet count levels. Platelet count levels were expressed in billion cells per liter (billion cells/L).'}, {'measure': 'Levels of Total Bilirubin in Blood Samples - Step 2', 'timeFrame': 'At Day 0 (PRE), Day 30, Day 32, Day 37, Day 60 for the HBsAg/AS_2 Group and Day 0 (PRE) Day 180, Day 182, Day 187 and Day 210 for the Engerix-B_2 Group', 'description': 'Biochemical laboratory parameters assessed included total bilirubin levels. Bilirubin concentrations were expressed in milligrams per deciliter (mG/dL).'}, {'measure': 'Levels of Diastolic Blood Pressure - Step 2', 'timeFrame': 'At Day 0 (PRE), Day 30 (H0, H6) at Day 31, at Day 32, at Day 37, at Day 60 for the HBsAg/AS_2 Group and at Day 0 (PRE), Day 180 (H0, H6), Day 181, at Day 182, at Day 187 and at Day 210 for the Engerix-B_2 Group', 'description': 'Diastolic pressure was part of the list of vital signs followed at specific protocol-defined time points during this study, measured in millimeter of mercury (mmHg). On Days 30 and 180, diastolic blood pressure was assessed at multiple time points (plus 0 and 6 hours - H0, H6).'}, {'measure': 'Levels of Heart Rate - Step 2', 'timeFrame': 'At Day 0 (PRE), Day 30 (H0, H6) at Day 31, at Day 32, at Day 37, at Day 60 for the HBsAg/AS_2 Group and at Day 0 (PRE), Day 180 (H0, H6), Day 181, at Day 182, at Day 187 and at Day 210 for the Engerix-B_2 Group', 'description': 'Heart rate was part of the list of vital signs followed at specific protocol-defined time points during this study. It was expressed in beats per minute. On Days 30 and 180, heart rate was assessed at multiple time points (plus 0 and 6 hours - H0, H6).'}, {'measure': 'Levels of Respiratory Rate - Step 2', 'timeFrame': 'At Day 0 (PRE), Day 30 (H0, H6) at Day 31, at Day 32, at Day 37, at Day 60 for the HBsAg/AS_2 Group and at Day 0 (PRE), Day 180 (H0, H6), Day 181, at Day 182, at Day 187 and at Day 210 for the Engerix-B_2 Group', 'description': 'Respiratory Rate was part of the list of vital signs followed at specific protocol-defined time points during this study. It was expressed as breaths per minute (breaths/min). On Days 30 and 180, respiratory rate was assessed at multiple time points (plus 0 and 6 hours - H0, H6).'}, {'measure': 'Levels of Systolic Pressure - Step 2', 'timeFrame': 'At Day 0 (PRE), Day 30 (H0, H6) at Day 31, at Day 32, at Day 37, at Day 60 for the HBsAg/AS_2 Group and at Day 0 (PRE), Day 180 (H0, H6), Day 181, at Day 182, at Day 187 and at Day 210 for the Engerix-B_2 Group', 'description': 'Systolic pressure was part of the list of vital signs followed at specific protocol-defined time points during this study, measured in millimeter of mercury (mmHg). On Days 30 and 180, systolic pressure was assessed at multiple time points (plus 0 and 6 hours - H0, H6).'}, {'measure': '-Frequency of Hepatitis B Virus (HBs)-Specific Cluster of Differentiation (CD)4+ T-cells Expressing at Least 2 Immune Markers - Step 1', 'timeFrame': 'At Day 0 prior to vaccination (PRE) and Day 44 post-vaccination', 'description': 'Markers expressed were Interleukin-2 (IL-2), Interferon gamma (IFN-γ), Tumor Necrosis Factor (TNF)-α and Cluster of differentiation 40-Ligand (CD40L), as measured by classical (qualified assay) Intracellular Cytokine Staining (ICS),using frozen Peripheral blood mononuclear cells (PBMCs).'}, {'measure': 'Frequency of Hepatitis B Virus (HBs)-Specific Cluster of Differentiation (CD)4+ T-cells Expressing at Least 2 Immune Markers - Step 1', 'timeFrame': 'At Day 0 prior to vaccination (PRE), Day 44 and Day 180 post-vaccination', 'description': 'Markers expressed were Interleukin-2 (IL-2), Interferon gamma (IFN-γ), Tumor Necrosis Factor (TNF)-α and Cluster of differentiation 40-Ligand (CD40L), as measured by classical (qualified assay) Intracellular Cytokine Staining (ICS),using frozen Peripheral blood mononuclear cells (PBMCs).'}, {'measure': 'Frequency of Hepatitis B Virus (HBs)-Specific Cluster of Differentiation (CD)8+ T-cells Expressing at Least 2 Immune Markers - Step 1', 'timeFrame': 'At Day 0 prior to vaccination (PRE) and Day 44 post-vaccination', 'description': 'Markers expressed were Interleukin-2 (IL-2), Interferon gamma (IFN-γ), Tumor Necrosis Factor (TNF)-α and Cluste of differentiation 40-Ligand (CD40L), as measured by classical (qualified assay) Intracellular Cytokine Staining (ICS),using frozen Peripheral blood mononuclear cells (PBMCs).'}, {'measure': 'Frequency of Hepatitis B Virus (HBs)-Specific Cluster of Differentiation (CD)8+ T-cells Expressing at Least 2 Immune Markers - Step 1', 'timeFrame': 'At Day 0 prior to vaccination (PRE), Day 44 and Day 180 post-vaccination', 'description': 'Markers expressed were Interleukin-2 (IL-2), Interferon gamma (IFN-γ), Tumor Necrosis Factor (TNF)-α and Cluster of differentiation 40-Ligand (CD40L), as measured by classical (qualified assay) Intracellular Cytokine Staining (ICS),using frozen Peripheral blood mononuclear cells (PBMCs).'}, {'measure': 'Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 2', 'timeFrame': 'Up to 3 days post-placebo/vaccine administration.', 'description': 'Assessed solicited symptoms were fever \\[defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)\\], pain, redness \\[spreading beyond 20 millimeters (mm) of injection site\\], induration \\[spreading beyond 20 millimeters (mm) of injection site\\], swelling \\[spreading beyond 20 millimeters (mm) of injection site\\] and muscle stiffness.'}, {'measure': 'Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Pooling Step', 'timeFrame': 'Up to 3 days post-Dose 2 vaccine administration in HBsAg/AS_1+2 Group', 'description': 'Assessed solicited symptoms were fever \\[defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)\\], pain, redness \\[spreading beyond 20 millimeters (mm) of injection site\\], induration \\[spreading beyond 20 millimeters (mm) of injection site\\], swelling \\[spreading beyond 20 millimeters (mm) of injection site\\] and muscle stiffness.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Adults', 'Reactogenicity', 'Naive', 'Immune responses', 'Read-outs', 'Hepatitis B', 'Healthy'], 'conditions': ['Hepatitis B']}, 'referencesModule': {'references': [{'pmid': '39083587', 'type': 'DERIVED', 'citation': 'Bechtold V, Smolen KK, Burny W, de Angelis SP, Delandre S, Essaghir A, Marchant A, Ndour C, Taton M, van der Most R, Willems F, Didierlaurent AM. Functional and epigenetic changes in monocytes from adults immunized with an AS01-adjuvanted vaccine. Sci Transl Med. 2024 Jul 31;16(758):eadl3381. doi: 10.1126/scitranslmed.adl3381. Epub 2024 Jul 31.'}, {'pmid': '35367070', 'type': 'DERIVED', 'citation': 'Burny W, Herve C, Caubet M, Yarzabal JP, Didierlaurent AM. Utility of urinary cytokine levels as predictors of the immunogenicity and reactogenicity of AS01-adjuvanted hepatitis B vaccine in healthy adults. Vaccine. 2022 Apr 26;40(19):2714-2722. doi: 10.1016/j.vaccine.2022.03.050. Epub 2022 Mar 30.'}, {'pmid': '30850240', 'type': 'DERIVED', 'citation': 'Burny W, Marchant A, Herve C, Callegaro A, Caubet M, Fissette L, Gheyle L, Legrand C, Ndour C, Tavares Da Silva F, van der Most R, Willems F, Didierlaurent AM, Yarzabal J; ECR-008 study group. Inflammatory parameters associated with systemic reactogenicity following vaccination with adjuvanted hepatitis B vaccines in humans. Vaccine. 2019 Mar 28;37(14):2004-2015. doi: 10.1016/j.vaccine.2019.02.015. Epub 2019 Mar 5.'}]}, 'descriptionModule': {'briefSummary': "This study aims to develop innovative immunological read-outs and new technologies in order to further characterise the early immune response and its kinetics as well as the adaptive immune responses to adjuvanted vaccines.\n\nThis study will also evaluate the reactogenicity in healthy, hepatitis B virus naive adults vaccinated with the hepatitis B surface antigen in combination with a GSK Biologicals' Adjuvant System.", 'detailedDescription': 'This study will be conducted in 2 steps with 2 study groups in each step. The entire study period for Step 1 is from Day -30 to Day 210 (240 days) The entire study period for Step 2 is from Day 0 to Day 180 for Group C and from Day 0 to Day 330 for Group D.\n\nSubjects will be blinded up to Day 60 in Step 1 and will be unblinded at the end of their Day 60 visit. Step 2 will be conducted in an open-label manner.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol\n* A male or female between, and including, 18 and 45 years of age at the time of first study product administration\n* Written informed consent obtained from the subject\n* Healthy subjects, in the opinion of the investigator, as established by medical history, clinical examination, and clinical laboratory assessment with no active disease that could interfere with the study endpoints, before entering into the study\n* Body Mass Index (BMI) between 18.5 and 30 kg/m2\n* Female subjects of non-childbearing potential may be enrolled in the study\n\n \\- Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause.\n* Female subjects of childbearing potential may be enrolled in the study, if the subject:\n\n * has practiced adequate contraception for 30 days prior to first study product administration and\n * has a negative pregnancy test on the day of placebo administration/ vaccination, and\n * has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the study.\n\nExclusion Criteria:\n\n* Known history of HBV infection.\n* Previous vaccination against hepatitis B.\n* Positive for anti-hepatitis B surface (HBs) antibodies, anti-hepatitis B core (HBc) antibodies, HBsAg, HCV antibodies and/or HIV.\n* Any previous administration of vaccine components.\n* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first study product administration, or planned use during the study period.\n* No significant dietary restrictions or life-threatening food allergies.\n* Regular use of non steroidal anti-inflammatory drugs within 1 month prior to first study product administration.\n* Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within 6 months prior to the first study product administration.. Inhaled and topical steroids are allowed.\n* Planned administration / administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the first study product administration and during the entire study period (both Steps), with the exception of the influenza vaccine (pandemic or seasonal) which can be administered \\> 21 days preceding or \\> 21 days following each placebo/vaccine administration.\n* Administration of immunoglobulins and/or any blood products within the last 3 months preceding the first study product administration or planned administration during the study period.\n* Any confirmed or suspected immunosuppressive or immunodeficient condition, including HIV based on screening evaluations and on medical history and physical examination.\n* History of or current bleeding or coagulation disorder.\n* Any known or clinical signs of anaemia or any clinical condition (including vascular disorder) that would preclude frequent blood drawings.\n* Poor venous access as assessed at screening by the investigator.\n* Blood loss, including blood donation, of more than 300 mL within 90 days before the first study product administration.\n* History of or current autoimmune or other immune-mediated disease.\n* Any haematological or biochemical level out of normal range before entering into the study, as follows:\n* Haemoglobin level \\< lower normal limit (LNL).\n* Platelet counts out of normal range.\n* Alanine aminotransferase \\[ALT\\] \\> upper normal limit (UNL).\n* Aspartate aminotransferase \\[AST\\] \\> UNL.\n* Creatinine \\> UNL.\n* c-reactive protein \\[CRP\\] \\> UNL.\n* Creatine phosphokinase \\[CPK\\] \\> UNL without any plausible explanation for this abnormality (such as sport activity).\n\nIn case of haematological and/or biochemical value out of range for parameters mentioned here above, one re-testing of out of range value may be performed.\n\n* Any acute or chronic, clinically significant disease, as determined by medical history, physical examination or laboratory screening tests.\n* Known or suspected reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.\n* Acute disease and/or fever at the time of enrolment.\n* Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator.\n* Fever is defined as temperature ≥ 37.5°C for oral route.\n* Pregnant or lactating female.\n* Recent history of chronic alcohol consumption and/or drug abuse.\n* Other conditions that the principal investigator judges may interfere with study findings.'}, 'identificationModule': {'nctId': 'NCT01777295', 'briefTitle': "Development of Read-outs in Healthy, Hepatitis B Virus Naive Adults Vaccinated With the Hepatitis B Surface Antigen (HBsAg) in Combination With a GlaxoSmithKline (GSK) Biologicals' Adjuvant System", 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': "Development of Read-outs to Detect and Characterise the Early and Adaptive Immune Responses in Healthy, Hepatitis B Virus Naive Adults Vaccinated With the Hepatitis B Surface Antigen in Combination With a GSK Biologicals' Adjuvant System", 'orgStudyIdInfo': {'id': '116640'}, 'secondaryIdInfos': [{'id': '2012-001344-22', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HBsAg/AS Group', 'description': 'Subjects in this group received 1 dose of Placebo at Day -30 followed by 2 doses of HBsAg/AS, at Day 0 and Day 30.', 'interventionNames': ['Biological: Adjuvanted Hepatitis B surface antigen (HBsAg) candidate vaccine GSK2231392A.', 'Biological: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Engerix-B Group', 'description': 'Subjects in this group received 1 dose of Placebo at Day -30 followed by 3 doses of Engerix-B at Day 0, Day 30 and Day 180.', 'interventionNames': ['Biological: EngerixTM-B', 'Biological: Placebo']}], 'interventions': [{'name': 'Adjuvanted Hepatitis B surface antigen (HBsAg) candidate vaccine GSK2231392A.', 'type': 'BIOLOGICAL', 'otherNames': ['HBsAg/AS'], 'description': 'Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.', 'armGroupLabels': ['HBsAg/AS Group']}, {'name': 'EngerixTM-B', 'type': 'BIOLOGICAL', 'otherNames': ['Engerix-B'], 'description': 'Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.', 'armGroupLabels': ['Engerix-B Group']}, {'name': 'Placebo', 'type': 'BIOLOGICAL', 'description': 'Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.', 'armGroupLabels': ['Engerix-B Group', 'HBsAg/AS Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2060', 'city': 'Antwerp', 'country': 'Belgium', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Region of Wallonia', 'class': 'UNKNOWN'}, {'name': 'Public Private Partnership with Institute for Medical Immunology (Universite Libre de Bruxelles)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}